HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
FDA 510(k) clearance K991569 · decided 1999-08-03
Clearance details
- K-number
- K991569
- Device name
- HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
- Applicant
- 02 Marketing Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-05
- Decision date
- 1999-08-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Saf recall (Z-0929-03) | System 02 Inc | 2003-06-12 |