The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Vista Avs.
| Device ID | K063600 |
| 510k Number | K063600 |
| Device Name: | VISTA AVS |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | SUMMIT DOPPLER SYSTEMS, INC. 4620 TECHNOLOGY DR. UNIT 100 Golden, CO 80403 |
| Contact | Ken Jarrell |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-12-04 |
| Decision Date | 2006-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479199659 | K063600 | 000 |
| 00888937002027 | K063600 | 000 |
| 00888937001990 | K063600 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISTA AVS 85453221 4160952 Live/Registered |
CooperSurgical, Inc. 2011-10-21 |