COLOR FLOW IMAGING

System, Imaging, Pulsed Echo, Ultrasonic

ADVANCED TECHNOLOGY LABORATORIES, INC.

The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Color Flow Imaging.

Pre-market Notification Details

Device IDK873096
510k NumberK873096
Device Name:COLOR FLOW IMAGING
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell,  WA  98041 -3003
ContactJohn Dellinger
CorrespondentJohn Dellinger
ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell,  WA  98041 -3003
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-07
Decision Date1987-11-23

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