510(k) K142764
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2015
- Date Received
- September 25, 2014
- 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