Miniox 1A
by Ohio Medical LLC 2 variants
Miniox 1A is a Class II device made by Ohio Medical LLC, cleared under FDA 510(k) K961644 on 25 Jul 1996 and listed in FDA GUDID since 30 Apr 2020 (UDI-DI 00628101609184), 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 | Number00628101609184 | Date30 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961644 | Date25 Jul 1996 | StatusActive |
Official records
- AccessGUDID record 00628101609184
- FDA 510(k) database K961644
Across registries
- FDA 510(k) K961644 decided 25 Jul 1996 Active
- FDA GUDID UDI-DI 00628101609184 listed 30 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K961644
- Listed FDA GUDID 00628101609184
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MiniOX
- Generic name
- Respiratory oxygen monitor, battery-powered
- Model / reference
- MINIOX 1A
- Primary DI / UDI-DI
- 00628101609184
- 510(k) Number
- FDA product code
- CCL
- GMDN term
- Respiratory oxygen monitor, battery-powered
- Device class
- Class II
- Regulation number
- 868.1720
- GUDID distribution status
- In Commercial Distribution
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