Data / Medical devices / France / Impeto Medical
Impeto Medical: FDA-registered device maker in Issy-les-Moulineaux Ile-de-France, France, 1 510(k) clearance
Impeto Medical is registered with the FDA (registration 3008496197) in Issy-les-Moulineaux Ile-de-France, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 14, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008496197
- Address
- 2 Rue Maurice Hartmann, Issy-les-Moulineaux Ile-de-France, France, 92130
- Owner or operator
- Withings (France) (10035674)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 30, 2022
- Registered through
- 2026
- Brand names listed
- SUDOSCAN, SUDOSCAN S, SUDOSCAN2, SmartSKAN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Galvanic Skin Response Measurement | GZO | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 14, 2010 | K100233 | SUDOSCAN | GZO | Substantially Equivalent | Impeto Medical | accessdata.fda.gov |
Compare with other makers
Updated June 14, 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.