510(k) K042374
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2004
- Date Received
- September 1, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Pump Speed, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4380
- Review Panel
- CV
- Submission Type