NIKOMED TRACE 1 ECG ELECTRODES

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 Nikomed Trace 1 Ecg Electrodes.

Pre-market Notification Details

Device IDK022909
510k NumberK022909
Device Name:NIKOMED TRACE 1 ECG ELECTRODES
ClassificationElectrode, Electrocardiograph
Applicant NIKOMED U.S.A., INC. P.O. BOX 560 Stillwater,  MN  55082
ContactElaine Duncan
CorrespondentElaine Duncan
NIKOMED U.S.A., INC. P.O. BOX 560 Stillwater,  MN  55082
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-03
Decision Date2003-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30853512006487 K022909 000
00853512006806 K022909 000

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