VISTA AVS

Monitor, Ultrasonic, Nonfetal

SUMMIT DOPPLER SYSTEMS, INC.

The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Vista Avs.

Pre-market Notification Details

Device IDK063600
510k NumberK063600
Device Name:VISTA AVS
ClassificationMonitor, Ultrasonic, Nonfetal
Applicant SUMMIT DOPPLER SYSTEMS, INC. 4620 TECHNOLOGY DR. UNIT 100 Golden,  CO  80403
ContactKen Jarrell
CorrespondentLaura Danielson
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeJAF  
CFR Regulation Number892.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-12-04
Decision Date2006-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40612479199659 K063600 000
00888937002027 K063600 000
00888937001990 K063600 000

Trademark Results [VISTA AVS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISTA AVS
VISTA AVS
85453221 4160952 Live/Registered
CooperSurgical, Inc.
2011-10-21

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