Analyzer MaxO2+
Analyzer MaxO2+ (R219P20-009) is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K040484 on 9 Jun 2004 and listed in FDA GUDID since 14 Aug 2024 (UDI-DI 00817770025849), 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 | Number00817770025849 | Date14 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040484 | Date9 Jun 2004 | StatusActive |
Official records
- AccessGUDID record 00817770025849
- FDA 510(k) database K040484
Across registries
- FDA 510(k) K040484 decided 9 Jun 2004 Active
- FDA GUDID UDI-DI 00817770025849 listed 14 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K040484
- Listed FDA GUDID 00817770025849
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Analyzer
- Generic name
- Respiratory oxygen monitor, line-powered
- Model / Ref / Catalog
- MaxO2+, R219P20-009
- Primary DI / UDI-DI
- 00817770025849
- 510(k) Number
- FDA product code
- CCL
- GMDN term
- Respiratory oxygen monitor, line-powered
- Device class
- Class II
- Regulation number
- 868.1720
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).
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- OXYGEN MEDICELS, CITICELS by City Technology Limited
- NO. 100352 GALVANIC OXYGEN SENSOR by VASCULAR TECHNOLOGY, INCORPORATED
- PRO2 CHECK OXYGEN INDICATOR by Medical Technology Specialists, Inc.
- O2-Sensor M-08T 47 00 22 by IT Dr. Gambert GmbH
- OXITRON OXYGEN ANALYZER by Oxitron Medical Products
- TED 191 by Teledyne Brown Engineering