Data / Medical devices / Computer, Blood-Pressure
Computer, Blood-Pressure (DSK): 67 FDA-registered makers in 17 countries
67 establishments in 17 countries are registered with the FDA to make Computer, Blood-Pressure (product code DSK, Class 2, 21 CFR 870.1110). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 77 510(k) clearances under this code, the latest on November 3, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DSK
- Device class
- 2
- Regulation
- 870.1110
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 30 |
| China | 12 |
| Germany | 5 |
| Australia | 2 |
| Singapore | 2 |
| Finland | 2 |
| Taiwan | 2 |
| Japan | 2 |
| Norway | 2 |
| Canada | 1 |
| Mexico | 1 |
| Poland | 1 |
| South Korea | 1 |
| Dominican Republic | 1 |
| Brazil | 1 |
| United Kingdom | 1 |
| India | 1 |
Makers of Computer, Blood-Pressure
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ATCOR MEDICAL Pty Ltd | SYDNEY New South Wales, Australia | Manufacturer, Specification developer | 3 | April 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Singapore Pte. Ltd. | SINGAPORE Central Singapore, Singapore | Manufacturer | 1 | January 25, 1989 | 0 | 0 | 0 | api.fda.gov |
| Scottcare Corporation | Cleveland, OH, United States | Manufacturer | 1 | July 24, 2002 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol DC Electronics | San Jose, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Andon Health Co., Ltd | Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Westford, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadex Electronics, Inc. | RICHMOND British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contec Medical Systems Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digicare Biomedical Technology, Inc. | Boynton Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DT Research, Inc Taiwan Branch | New Taipei City, Taiwan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emi (dongguan) Asia Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fukuda Denshi Co., Ltd. | Shiroi-shi Chiba, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fukuda Denshi Co., Ltd. | Bunkyo-ku Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Biolight Meditech Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GWW | Gaertringen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediana Co., Ltd. | Wonju-Si, Gangwon-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medistim Asa | HORTEN Vestfold, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medistim Asa | Oslo, Norway | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Dominicana, S.A.S. | Las Americas Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physio-Control, Inc. | Redmond, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Goldway (Shenzhen) Industrial Inc. | SHENZHEN Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Ltda | Varginha Minas Gerais, Brazil | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tresmine Pty Ltd T/A Circuitwise Electronics | Bella vista New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volcano Corporation | Rancho Cordova, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volcano Corporation | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zurich Medical Inc | Plymouth, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.