Disposable Pressure Manometer 1
Disposable Pressure Manometer 1 (566) 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 28 Feb 2020 (UDI-DI 00851232007752), 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 | Number00851232007752 | Date28 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192000 | Date19 Feb 2020 | StatusActive |
Official records
- AccessGUDID record 00851232007752
- FDA 510(k) database K192000
Across registries
- FDA 510(k) K192000 decided 19 Feb 2020 Active
- FDA GUDID UDI-DI 00851232007752 listed 28 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K192000
- Listed FDA GUDID 00851232007752
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Disposable Pressure Manometer
- Generic name
- Airway pressure monitor, non-powered
- Model / Ref / Catalog
- 1, 566
- Primary DI / UDI-DI
- 00851232007752
- 510(k) Number
- FDA product code
- CAP
- GMDN term
- Airway pressure monitor, non-powered
- Device class
- Class II
- Regulation number
- 868.2600
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Airway pressure monitor, non-powered.