510(k) K012747
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2001
- Date Received
- August 16, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Blood-Flow, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2120
- Review Panel
- CV
- Submission Type