Data / Medical devices / France / Manatec
Manatec: FDA-registered device maker in Poissy Ile-de-France, France, 3 510(k) clearances
Manatec is registered with the FDA (registration 1000610255) in Poissy Ile-de-France, France. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 12, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000610255
- Address
- 10 bis Rue Jacob Courant, Poissy Ile-de-France, France, 78300
- Owner or operator
- Manatec SARL (10028447)
- Roles
- Manufacturer
- First device listed
- January 30, 2009
- Registered through
- 2026
- Brand names listed
- PF07 Enduro, PF07 Q-Link, PhysioFlow Enduro, PhysioFlow Q-Link, PhysioFlow System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | 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 12, 2014 | K140102 | PHYSIOFLOW Q-LINK | DSB | Substantially Equivalent | Vasocom, Inc. | accessdata.fda.gov |
| December 3, 2010 | K103283 | PHYSIOFLOW ENDURO | DSB | Substantially Equivalent | Vasocom, Inc. | accessdata.fda.gov |
| April 10, 2008 | K060387 | PHYSIOFLOW SYSTEM | DSB | Substantially Equivalent | Vasocom, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 12, 2014. 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.