QuantaFlo 91-0013
QuantaFlo 91-0013 is a Class II device made by Semler Scientific, Inc., cleared under FDA 510(k) K143094 on 5 Mar 2015 and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 00859433006048), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00859433006048 | Date19 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143094 | Date5 Mar 2015 | StatusActive |
Official records
- AccessGUDID record 00859433006048
- FDA 510(k) database K143094
Across registries
- FDA 510(k) K143094 decided 5 Mar 2015 Active
- FDA GUDID UDI-DI 00859433006048 listed 19 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K143094
- Listed FDA GUDID 00859433006048
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuantaFlo
- Generic name
- Limb plethysmograph
- Model / reference
- 91-0013
- Primary DI / UDI-DI
- 00859433006048
- 510(k) Number
- FDA product code
- JOM
- GMDN term
- Limb plethysmograph
- Device class
- Class II
- Regulation number
- 870.2780
- GUDID distribution status
- Not in Commercial Distribution
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