510(k) K883359
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 1989
- Date Received
- August 10, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type