510(k) K970371
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1997
- Date Received
- January 31, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conserver, Oxygen
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type