510(k) K081429
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2008
- Date Received
- May 21, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Nonfetal
- Device Class
- Class II
- Regulation Number
- 892.1540
- Review Panel
- RA
- Submission Type