RING ELECTRODE

Electrode, Cutaneous

CADWELL LABORATORIES, INC.

The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Ring Electrode.

Pre-market Notification Details

Device IDK933805
510k NumberK933805
Device Name:RING ELECTRODE
ClassificationElectrode, Cutaneous
Applicant CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
ContactCarlton M Cadwell
CorrespondentCarlton M Cadwell
CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-04
Decision Date1994-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840067101551 K933805 000
00840067101117 K933805 000
00840067100240 K933805 000
00840067100233 K933805 000

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