510(k) K233076
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2024
- Date Received
- September 26, 2023
- 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