Saros 15 AS007-1
by Caire Inc.
Saros 15 AS007-1 is a Class II device made by Caire Inc., cleared under FDA 510(k) K150930 on 18 Dec 2015 and listed in FDA GUDID since 13 Apr 2017 (UDI-DI M766AS00710), active as of 23 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 | NumberM766AS00710 | Date13 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150930 | Date18 Dec 2015 | StatusActive |
Official records
- FDA 510(k) database K150930
Across registries
- FDA 510(k) K150930 decided 18 Dec 2015 Active
- FDA GUDID UDI-DI M766AS00710 listed 13 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K150930
- Listed FDA GUDID M766AS00710
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Saros 15
- Generic name
- Mobile/portable oxygen concentrator
- Model / reference
- AS007-1
- Primary DI / UDI-DI
- M766AS00710
- 510(k) Number
- FDA product code
- CAW
- GMDN term
- Mobile/portable oxygen concentrator
- Device class
- Class II
- Regulation number
- 868.5440
- GUDID distribution status
- In Commercial Distribution
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