ECG MONITOR OSCILLOSCOPE MODEL OEC-3100

Electrocardiograph

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ecg Monitor Oscilloscope Model Oec-3100.

Pre-market Notification Details

Device IDK800005
510k NumberK800005
Device Name:ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
ClassificationElectrocardiograph
Applicant 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 Received1980-01-02
Decision Date1980-03-05

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