ELITE BIOFEEDBACK

Perineometer

LABORIE MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Elite Biofeedback.

Pre-market Notification Details

Device IDK942563
510k NumberK942563
Device Name:ELITE BIOFEEDBACK
ClassificationPerineometer
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. South Burlington,  VT  05403
ContactFred Buffa
CorrespondentFred Buffa
LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. South Burlington,  VT  05403
Product CodeHIR  
CFR Regulation Number884.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-31
Decision Date1995-06-06

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