Data / Medical devices / Germany / Cortex Biophysik GMBH
Cortex Biophysik GMBH: FDA-registered device maker in LEIPZIG Saxony, Germany, 2 510(k) clearances
Cortex Biophysik GMBH is registered with the FDA (registration 9680276) in LEIPZIG Saxony, Germany. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 22, 2001. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9680276
- FEI number
- 3010320336
- Address
- Walter-Koehn-Str. 2d, LEIPZIG Saxony, Germany, 04356
- Owner or operator
- CORTEX BIOPHYSIK GMBH (9007843)
- Roles
- Manufacturer
- First device listed
- January 7, 2008
- Registered through
- 2026
- Brand names listed
- MetaLyzer, MetaLyzer 3B, MetaMax, MetaMax 3B, MetaSoft, MetaSoft Studio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Manufacturer | accessdata.fda.gov |
| Calculator, Pulmonary Function Data | BZC | 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 |
|---|---|---|---|---|---|---|
| February 22, 2001 | K001631 | CORTEX METAMAX | BZC | Substantially Equivalent | Cortex Biophysik GmbH | accessdata.fda.gov |
| December 14, 2000 | K993641 | METALYZER, MODEL 2; METALYZER, MODEL 3 | BTY | Substantially Equivalent | Cortex Biophysik GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Calculator, Predicted Values, Pulmonary Function
- All makers of Calculator, Pulmonary Function Data
Updated February 22, 2001. 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.