510(k) K163657
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2017
- Date Received
- December 23, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type