510(k) K062401
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2006
- Date Received
- August 16, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Compressor, Cardiac, External
- Device Class
- Class II
- Regulation Number
- 870.5200
- Review Panel
- CV
- Submission Type