Data / Medical devices / United States / BioClinica, Inc.
BioClinica, Inc.: FDA-registered device maker in Philadelphia, PA, United States, 15 510(k) clearances
BioClinica, Inc. is registered with the FDA (registration 1126271) in Philadelphia, PA, United States. It lists 9 device types. The FDA files 15 510(k) clearances under its listings, the newest dated November 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1126271
- FEI number
- 1000263641
- Address
- 1818 Market Street, Philadelphia, PA, United States, 19103
- Owner or operator
- Bioclinica, Inc. (10023650)
- Roles
- Repackager or relabeler
- First device listed
- December 15, 2009
- Registered through
- 2026
- Brand names listed
- 90217A, Clarius L20 HD3, Endoflip nasal tip catheter, GI M12R, H12+, IEM HMS-CS, MAC 1200, Tel-O-Graph and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Repackager or relabeler | accessdata.fda.gov |
| LOS | LOS | Repackager or relabeler | accessdata.fda.gov | |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 15, 2021 | K213436 | Clarius Ultrasound Scanner | IYN | Substantially Equivalent | Clarius Mobile Health Corp. | accessdata.fda.gov |
| June 18, 2020 | K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 16, 2019 | K173895 | Tel-O-Graph | DXN | Substantially Equivalent | I.E.M. Industrielle Entwicklung and Medizintechnik | accessdata.fda.gov |
| February 15, 2019 | K183072 | EndoFLIP System | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| August 2, 2012 | K122073 | ELI 280 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| December 16, 2011 | K110603 | HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) | DXN | Substantially Equivalent | I.E.M. GmbH | accessdata.fda.gov |
| February 4, 2011 | K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR | DXN | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| July 2, 2010 | K101403 | ELI 250 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| June 18, 2010 | K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| May 28, 2010 | K101275 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| November 24, 2008 | K082881 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| January 11, 2008 | K073198 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| September 26, 2005 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| June 27, 2002 | K021373 | H12+HOLTER RECORDER | MWJ | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| March 12, 1998 | K973403 | CARDIOSMART ST | LOS | Substantially Equivalent | Marquette Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
Updated November 15, 2021. 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.