4000 AU ULTRASOUND IMAGING SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

BIOSOUND, INC.

The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for 4000 Au Ultrasound Imaging System.

Pre-market Notification Details

Device IDK944485
510k NumberK944485
Device Name:4000 AU ULTRASOUND IMAGING SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis,  IN  46250
ContactWayne Nethercutt
CorrespondentWayne Nethercutt
BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis,  IN  46250
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-13
Decision Date1995-05-24

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