5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER

Transducer, Ultrasonic, Obstetric

ADVANCED TECHNOLOGY LABORATORIES, INC.

The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for 5.0 Mhz Convex Array Intravaginal Transducer.

Pre-market Notification Details

Device IDK895647
510k NumberK895647
Device Name:5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
ClassificationTransducer, Ultrasonic, Obstetric
Applicant ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell,  WA  98041 -3003
ContactJ Sweeney
CorrespondentJ Sweeney
ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell,  WA  98041 -3003
Product CodeHGL  
CFR Regulation Number884.2960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-20
Decision Date1989-12-18

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