MARK 500 ULTRASOUOND 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 Mark 500 Ultrasouond System.

Pre-market Notification Details

Device IDK820364
510k NumberK820364
Device Name:MARK 500 ULTRASOUOND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ADVANCED TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-09
Decision Date1982-03-26

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