510(k) K900683
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1990
- Date Received
- February 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type