GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN

Echocardiograph

BIOSOUND, INC.

The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Genesis Ii, 2.5/5.0 Mhz S.e/5.0mhz/3.5 16/19 Mm An.

Pre-market Notification Details

Device IDK873032
510k NumberK873032
Device Name:GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
ClassificationEchocardiograph
Applicant BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis,  IN  46250
ContactRobert Courtney
CorrespondentRobert Courtney
BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis,  IN  46250
Product CodeDXK  
CFR Regulation Number870.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-04
Decision Date1988-02-18

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