Data / Medical devices / Germany / Osypka Medical GMBH
Osypka Medical GMBH: FDA-registered device maker in Berlin, Germany, 5 510(k) clearances
Osypka Medical GMBH is registered with the FDA (registration 9681449) in Berlin, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 9, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681449
- FEI number
- 3007486998
- Address
- Albert-Einstein-Strasse 3, Berlin, Germany, 12489
- Owner or operator
- Osypka Medical GmbH (9029408)
- Roles
- Manufacturer
- First device listed
- October 31, 2007
- Registered through
- 2026
- Brand names listed
- AESCULON, ICON, Medtronic 5391, Model 3077, Model 3085, PACE 101, PACE 101H, PACE 203 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | 2 | Manufacturer | accessdata.fda.gov |
| Pulse-Generator, Pacemaker, External | DTE | 2 | Manufacturer | accessdata.fda.gov |
| Tester, Pacemaker Electrode Function | DTA | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 9, 2013 | K123916 | PSA SERIES | DTE | Unknown | Osypka Medical, Inc. | accessdata.fda.gov |
| October 8, 2008 | K082242 | ICON, MODEL C3 | DSB | Substantially Equivalent | Osypka Medical, Inc. | accessdata.fda.gov |
| May 30, 2008 | K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 | DSB | Substantially Equivalent | Osypka Medical, Inc. | accessdata.fda.gov |
| October 31, 2003 | K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | DTE | Substantially Equivalent | Osypka Medical, Inc. | accessdata.fda.gov |
| June 14, 2002 | K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE | DTE | Substantially Equivalent | Osypka Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pulse-Generator, Pacemaker, External
- All makers of Tester, Pacemaker Electrode Function
- All makers of Plethysmograph, Impedance
Updated April 9, 2013. 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.