510(k) K171292
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2018
- Date Received
- May 2, 2017
- 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