510(k) K902654
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1990
- Date Received
- June 15, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4410
- Review Panel
- CV
- Submission Type