510(k) K072131
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2007
- Date Received
- August 2, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type