510(k) K111347
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2011
- Date Received
- May 13, 2011
- 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