DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540

Electrode, Electrocardiograph

NIKOMED U.S.A., INC.

The following data is part of a premarket notification filed by Nikomed U.s.a., Inc. with the FDA for Disposable Ecg Monitoring Electrode #4530, #4540.

Pre-market Notification Details

Device IDK950475
510k NumberK950475
Device Name:DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
ClassificationElectrode, Electrocardiograph
Applicant NIKOMED U.S.A., INC. 206 AIRPORT BLVD. Doylestown,  PA  18901
ContactDonald C Epstein
CorrespondentDonald C Epstein
NIKOMED U.S.A., INC. 206 AIRPORT BLVD. Doylestown,  PA  18901
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-03
Decision Date1995-11-14

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