ACUSON I5100 ULTRASOUND TRANSDUCER

System, Imaging, Pulsed Echo, Ultrasonic

ACUSON CORP.

The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson I5100 Ultrasound Transducer.

Pre-market Notification Details

Device IDK884632
510k NumberK884632
Device Name:ACUSON I5100 ULTRASOUND TRANSDUCER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
ContactStephen T Johnson
CorrespondentStephen T Johnson
ACUSON CORP. 1220 CHARLESTON RD. Mountain View,  CA  94039 -7393
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-07
Decision Date1989-01-13

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