DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE

Transducer, Ultrasonic, Obstetric

DIASONICS, INC.

The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Diasonics Transvaginal, Tv 7.5 Mhz Probe.

Pre-market Notification Details

Device IDK864908
510k NumberK864908
Device Name:DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
ClassificationTransducer, Ultrasonic, Obstetric
Applicant DIASONICS, INC. 1565 BARBER LN. Milipitas,  CA  95035
ContactGary M Agatep
CorrespondentGary M Agatep
DIASONICS, INC. 1565 BARBER LN. Milipitas,  CA  95035
Product CodeHGL  
CFR Regulation Number884.2960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-15
Decision Date1987-03-27

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