Data / Medical devices / France / Fim Medical
Fim Medical: FDA-registered device maker in Villeurbanne Cedex Rhone, France, 2 510(k) clearances
Fim Medical is registered with the FDA (registration 3005053770) in Villeurbanne Cedex Rhone, France. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005053770
- Address
- 51 Rue PRIMAT CS 60194, Villeurbanne Cedex Rhone, France, 69625
- Owner or operator
- FIM MEDICAL (9045096)
- Roles
- Manufacturer
- First device listed
- September 9, 2008
- Registered through
- 2026
- Brand names listed
- Audiolyser ADL Connect, Audiolyser ADL-20, DEPISTEO VISION TESTER, DMV Edition, Earpad covers, FF-1086 Face Cover, Q13, Single-use Nose Clip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | 2 | Manufacturer | accessdata.fda.gov |
| Audiometer | EWO | 2 | Manufacturer | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 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 |
|---|---|---|---|---|---|---|
| October 20, 2016 | K161676 | Q13 SPIROLYSER® | BZG | Substantially Equivalent | Fim Medical | accessdata.fda.gov |
| November 28, 2008 | K080278 | TABATABA COTESTER | CCJ | Substantially Equivalent | Fim Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Chart, Visual Acuity
- All makers of Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- All makers of Spirometer, Diagnostic
- All makers of Audiometer
Updated October 20, 2016. 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.