510(k) K123216
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2013
- Date Received
- October 15, 2012
- Clearance Type
- Traditional
- 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