510(k) K883988
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1988
- Date Received
- September 20, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Valve, Non-Rebreathing
- Device Class
- Class II
- Regulation Number
- 868.5870
- Review Panel
- AN
- Submission Type