EVOMATIC 8000/4000

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 Evomatic 8000/4000.

Pre-market Notification Details

Device IDK843815
510k NumberK843815
Device Name:EVOMATIC 8000/4000
ClassificationStimulator, Electrical, Evoked Response
Applicant DANTEC ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-28
Decision Date1985-05-31

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