STIMUPLEX-DIG-RC NERVE STIMULATOR

Stimulator, Nerve, Battery-powered

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Stimuplex-dig-rc Nerve Stimulator.

Pre-market Notification Details

Device IDK021033
510k NumberK021033
Device Name:STIMUPLEX-DIG-RC NERVE STIMULATOR
ClassificationStimulator, Nerve, Battery-powered
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeBXN  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-29
Decision Date2003-03-21
Summary:summary

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