Atos 70
Atos 70 (1125426) is a Class II device made by Respironics Inc., cleared under FDA 510(k) K121955 on 14 Dec 2012 and listed in FDA GUDID since 22 Jan 2016 (UDI-DI 00606959026711), 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 | Number00606959026711 | Date22 Jan 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121955 | Date14 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 00606959026711
- FDA 510(k) database K121955
Across registries
- FDA 510(k) K121955 decided 14 Dec 2012 Active
- FDA GUDID UDI-DI 00606959026711 listed 22 Jan 2016 Listed
Timeline
- Cleared FDA 510(k) K121955
- Listed FDA GUDID 00606959026711
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Atos
- Generic name
- Positive pressure airway secretion-clearing device
- Model / Ref / Catalog
- 70, 1125426
- Primary DI / UDI-DI
- 00606959026711
- 510(k) Number
- FDA product code
- NHJ
- GMDN term
- Positive pressure airway secretion-clearing device
- Device class
- Class II
- Regulation number
- 868.5905
- GUDID distribution status
- In Commercial Distribution
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