510(k) K151954
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2015
- Date Received
- July 15, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type