NKA MODELS AB-601G AND AB-621G

Electrocardiograph

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nka Models Ab-601g And Ab-621g.

Pre-market Notification Details

Device IDK900272
510k NumberK900272
Device Name:NKA MODELS AB-601G AND AB-621G
ClassificationElectrocardiograph
Applicant NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
ContactAlex Gerwer
CorrespondentAlex Gerwer
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 Received1990-01-10
Decision Date1990-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.