510(k) K063600
K063600 is an FDA 510(k) premarket notification submitted by Summit Doppler Systems, Inc. for the device "VISTA AVS". The FDA issued a decision of Substantially Equivalent on December 19, 2006. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Summit Doppler Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2006
- Date Received
- December 4, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Ultrasonic, Nonfetal
- Device Class
- Class II
- Regulation Number
- 892.1540
- Review Panel
- RA
- Submission Type