Data / Medical devices / Germany / It DR. Gambert GMBH
It DR. Gambert GMBH: FDA-registered device maker in WISMAR Mecklenburg-Western Pomerania, Germany, 1 510(k) clearance
It DR. Gambert GMBH is registered with the FDA (registration 9613449) in WISMAR Mecklenburg-Western Pomerania, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2000. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9613449
- FEI number
- 3002739067
- Address
- Hinter Dem Chor 21, WISMAR Mecklenburg-Western Pomerania, Germany, 23966
- Owner or operator
- IT DR. GAMBERT GMBH (9042424)
- Roles
- Manufacturer
- First device listed
- December 18, 2007
- Registered through
- 2027
- Brand names listed
- M-01, M-01L2, M-01T, M-01TL2, M-02, M-02L2, M-02T, M-02TL2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 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 |
|---|---|---|---|---|---|---|
| December 15, 2000 | K002384 | M-XX OXYGEN SENSORS | CCL | Substantially Equivalent | International Business Strategies | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2000. 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.