Data / Medical devices / France / Sedatelec
Sedatelec: FDA-registered device maker in IRIGNY Rhone, France, 2 510(k) clearances
Sedatelec is registered with the FDA (registration 8020802) in IRIGNY Rhone, France. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 3, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020802
- FEI number
- 5711
- Address
- Chemin Des Muriers, IRIGNY Rhone, France, F-69540
- Owner or operator
- SEDATELEC (8020802)
- Roles
- Manufacturer
- First device listed
- December 18, 2007
- Registered through
- 2026
- Brand names listed
- ASP Classic, ASP Gold, ASP Multi Classic, ASP Multi Gold, ASP Multi Titanium, ASP Titanium, BAT02 Glass rods, EAR LIGHT D (ELD) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 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 3, 2010 | K101267 | PREMIO 10 MOXA | ILY | Substantially Equivalent | Sedatelec | accessdata.fda.gov |
| April 26, 2006 | K060392 | ASP TITANIUM | MQX | Substantially Equivalent | Sedatelec | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Device, Pressure Applying
- All makers of Needle, Acupuncture, Single Use
Updated December 3, 2010. 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.