OXY-SERVE II OXYGEN CONSERVING REGULATOR
FDA 510(k) clearance K051988 · decided 2005-09-21
Clearance details
- K-number
- K051988
- Device name
- OXY-SERVE II OXYGEN CONSERVING REGULATOR
- Applicant
- Superior Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-22
- Decision date
- 2005-09-21
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc recall (Z-0529-2008) | Superior Products Inc | 2008-01-23 |