510(k) K251820
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2025
- Date Received
- June 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type