Data / Medical devices / Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) (CBR): 43 FDA-registered makers in 14 countries
43 establishments in 14 countries are registered with the FDA to make Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) (product code CBR, Class 2, 21 CFR 868.1700). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on October 5, 2011, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CBR
- Device class
- 2
- Regulation
- 868.1700
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| China | 7 |
| Germany | 5 |
| Finland | 3 |
| Japan | 3 |
| Mexico | 2 |
| India | 2 |
| Singapore | 1 |
| Sweden | 1 |
| Poland | 1 |
| Malaysia | 1 |
| United Kingdom | 1 |
| Estonia | 1 |
| Taiwan | 1 |
Makers of Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
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 |
|---|---|---|---|---|---|---|---|---|
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 2 | October 5, 2011 | 0 | 3 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | September 3, 1985 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 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 | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Specification developer | 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 | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frohe Sweden AB | Tyreso, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, 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 | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KB Components Finland Oy | Nurmijarvi Etela-Karjala, Finland | 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 | |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, 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 | |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Platinum Focus Group Ltd. | London London, City of, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 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 | 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 | |
| RAUMEDIC Estonia AS | Tallinn Harjumaa, Estonia | Contract 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Manufacturer | 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 | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 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 |
Updated October 5, 2011. 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.