ULTRAMARK 1 ULTRASOUND SYSTEM

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 Ultramark 1 Ultrasound System.

Pre-market Notification Details

Device IDK862681
510k NumberK862681
Device Name:ULTRAMARK 1 ULTRASOUND SYSTEM
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 Received1986-07-15
Decision Date1986-07-16

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