Flowmeter, CM Assy 27025
by Accutron
Flowmeter, CM Assy 27025 is a Class II device made by Accutron, cleared under FDA 510(k) K970163 on 10 Dec 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00813830023978), 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 | Number00813830023978 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK970163 | Date10 Dec 1997 | StatusActive |
Official records
- AccessGUDID record 00813830023978
- FDA 510(k) database K970163
Across registries
- FDA 510(k) K970163 decided 10 Dec 1997 Active
- FDA GUDID UDI-DI 00813830023978 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K970163
- Listed FDA GUDID 00813830023978
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flowmeter, CM Assy
- Generic name
- Oxygen/air/nitrous oxide breathing gas mixer
- Model / Ref / Catalog
- 27025
- Primary DI / UDI-DI
- 00813830023978
- 510(k) Number
- FDA product code
- BSZ
- GMDN term
- Oxygen/air/nitrous oxide breathing gas mixer
- Device class
- Class II
- Regulation number
- 868.5160
- GUDID distribution status
- In Commercial Distribution
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