Pelvital System

Perineometer

Pelvital USA, Inc.

The following data is part of a premarket notification filed by Pelvital Usa, Inc. with the FDA for Pelvital System.

Pre-market Notification Details

Device IDK200409
510k NumberK200409
Device Name:Pelvital System
ClassificationPerineometer
Applicant Pelvital USA, Inc. 1000 LaSalle Avenue, SCH 435 Minneapolis,  MN  55403
ContactDale Wahlstrom
CorrespondentCarrie Hetrick
Hetrick Medical Device Consulting LLC 19123 West 60th Lane Golden,  CO  80403
Product CodeHIR  
CFR Regulation Number884.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-19
Decision Date2020-07-10

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