Disposable Pressure Manometer 313-4000
by Engineered Medical Systems, LLC
Disposable Pressure Manometer 313-4000 is a Class II device made by Engineered Medical Systems, LLC, cleared under FDA 510(k) K003497 on 30 Nov 2000 and listed in FDA GUDID since 12 Apr 2025 (UDI-DI 00841470111700), 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 | Number00841470111700 | Date12 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK003497 | Date30 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00841470111700
- FDA 510(k) database K003497
Across registries
- FDA 510(k) K003497 decided 30 Nov 2000 Active
- FDA GUDID UDI-DI 00841470111700 listed 12 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K003497
- Listed FDA GUDID 00841470111700
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- Withdrawn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 / reference
- 313-4000
- Primary DI / UDI-DI
- 00841470111700
- 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