510(k) K081781
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2008
- Date Received
- June 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type