VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7

Transducer, Ultrasonic, Diagnostic

MEDISON AMERICA, INC.

The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Volusion Small Parts Transducer, Model S-vnw 5-10, Volusion Abdominal Transducer, Model S-vaw 4-7.

Pre-market Notification Details

Device IDK992155
510k NumberK992155
Device Name:VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactMichaela Mahl
CorrespondentCarole Stamp
TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-06-25
Decision Date1999-07-08
Summary:summary

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