WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES

Electrocardiograph

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Wec-7101a Pocket Size Ecg Monitor And Accessories.

Pre-market Notification Details

Device IDK002473
510k NumberK002473
Device Name:WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
ClassificationElectrocardiograph
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactBonnie Bishop
CorrespondentBonnie Bishop
NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-11
Decision Date2000-11-08

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