BX-400S

Stimulator, Muscle, Powered

BLOOMEX INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Bx-400s.

Pre-market Notification Details

Device IDK942195
510k NumberK942195
Device Name:BX-400S
ClassificationStimulator, Muscle, Powered
Applicant BLOOMEX INTERNATIONAL, INC. 295 MOLNAR DR. Elmwood Park,  NJ  07407 -3211
ContactBenjamin Laroux
CorrespondentBenjamin Laroux
BLOOMEX INTERNATIONAL, INC. 295 MOLNAR DR. Elmwood Park,  NJ  07407 -3211
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-12
Decision Date1995-08-14

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