ULTRASOUND BREAST SCANNING DEVICE

System, Imaging, Pulsed Echo, Ultrasonic

LIFE INSTRUMENT CORP.

The following data is part of a premarket notification filed by Life Instrument Corp. with the FDA for Ultrasound Breast Scanning Device.

Pre-market Notification Details

Device IDK781177
510k NumberK781177
Device Name:ULTRASOUND BREAST SCANNING DEVICE
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant LIFE INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-07-06
Decision Date1979-01-03

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