VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460

Stimulator, Muscle, Powered

METRON MEDICAL AUSTRALIA PTY LTD

The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Vectorsurge 4 Interferential Therapy Unit Model Vs 460.

Pre-market Notification Details

Device IDK003260
510k NumberK003260
Device Name:VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
ClassificationStimulator, Muscle, Powered
Applicant METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria,  AU 3201
ContactRob Hopkins
CorrespondentRob Hopkins
METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria,  AU 3201
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-18
Decision Date2001-02-22

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