MAXO2ME R230P01-002
by Maxtec, Inc.
MAXO2ME R230P01-002 is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K153659 on 10 Jun 2016 and listed in FDA GUDID since 27 Mar 2018 (UDI-DI 00853061006968), 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 | Number00853061006968 | Date27 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153659 | Date10 Jun 2016 | StatusActive |
Official records
- AccessGUDID record 00853061006968
- FDA 510(k) database K153659
Across registries
- FDA 510(k) K153659 decided 10 Jun 2016 Active
- FDA GUDID UDI-DI 00853061006968 listed 27 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K153659
- Listed FDA GUDID 00853061006968
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MAXO2ME
- Generic name
- Respiratory oxygen monitor, battery-powered
- Model / reference
- R230P01-002
- Primary DI / UDI-DI
- 00853061006968
- 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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