FEATHERLITE AQUA TOCODYNAMOMETER

Monitor, Uterine Contraction, External (for Use In Clinic)

VENTREX, INC.

The following data is part of a premarket notification filed by Ventrex, Inc. with the FDA for Featherlite Aqua Tocodynamometer.

Pre-market Notification Details

Device IDK061044
510k NumberK061044
Device Name:FEATHERLITE AQUA TOCODYNAMOMETER
ClassificationMonitor, Uterine Contraction, External (for Use In Clinic)
Applicant VENTREX, INC. 3007 BUNSEN AVE. SUITE K Ventura,  CA  93003
ContactGeorge Austria
CorrespondentGeorge Austria
VENTREX, INC. 3007 BUNSEN AVE. SUITE K Ventura,  CA  93003
Product CodeHFM  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-14
Decision Date2006-07-12
Summary:summary

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