ELECTROCARDIOGRAPH

Electrocardiograph

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Electrocardiograph.

Pre-market Notification Details

Device IDK865031
510k NumberK865031
Device Name:ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
Applicant NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
ContactJan Sebens
CorrespondentJan Sebens
NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-23
Decision Date1987-02-19

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