DNAP Electrode

Electrode, Depth

Ad-Tech Medical Instrument Corporation

The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corporation with the FDA for Dnap Electrode.

Pre-market Notification Details

Device IDK152547
510k NumberK152547
Device Name:DNAP Electrode
ClassificationElectrode, Depth
Applicant Ad-Tech Medical Instrument Corporation 1901 William Street Racine,  WI  53404
ContactLisa Theama
CorrespondentGary J Syring
QUALITY & REGULATORY ASSOCIATES, LLC. 800 LEVANGER LANE. Stoughton,  WI  53589
Product CodeGZL  
CFR Regulation Number882.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-08
Decision Date2016-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
90841823106622 K152547 000

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