510(k) K221782
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2023
- Date Received
- June 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type