OP3/VP4

Transducer, Ultrasonic, Obstetric

HUNTLEIGH TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Op3/vp4.

Pre-market Notification Details

Device IDK924516
510k NumberK924516
Device Name:OP3/VP4
ClassificationTransducer, Ultrasonic, Obstetric
Applicant HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan,  NJ  07726
ContactAndy Wood
CorrespondentAndy Wood
HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan,  NJ  07726
Product CodeHGL  
CFR Regulation Number884.2960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-04
Decision Date1993-06-28

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