OxyPAP 1
OxyPAP 1 (562) is a Class II device made by D R Burton Healthcare, LLC, cleared under FDA 510(k) K192000 on 19 Feb 2020 and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 00851232007714), active 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 | Number00851232007714 | Date24 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192000 | Date19 Feb 2020 | StatusActive |
Official records
- AccessGUDID record 00851232007714
- FDA 510(k) database K192000
Across registries
- FDA 510(k) K192000 decided 19 Feb 2020 Active
- FDA GUDID UDI-DI 00851232007714 listed 24 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K192000
- Listed FDA GUDID 00851232007714
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OxyPAP
- Generic name
- Airway pressure monitor, non-powered
- Model / Ref / Catalog
- 1, 562
- Primary DI / UDI-DI
- 00851232007714
- 510(k) Number
- FDA product code
- BWF, CAP
- GMDN term
- Airway pressure monitor, non-powered
- Device class
- Class II
- Regulation number
- 868.5690, 868.2600
- GUDID distribution status
- In Commercial Distribution
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