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 |