DANTEC MAGNETIC STIMULATOR

Stimulator, Electrical, Evoked Response

DANTEC ELECTRONICS, INC.

The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Dantec Magnetic Stimulator.

Pre-market Notification Details

Device IDK881915
510k NumberK881915
Device Name:DANTEC MAGNETIC STIMULATOR
ClassificationStimulator, Electrical, Evoked Response
Applicant DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale,  NJ  07401
ContactHenrik Henriksen
CorrespondentHenrik Henriksen
DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale,  NJ  07401
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-09
Decision Date1988-10-17

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