NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Ecg-9320a Cardiofax And Accessories.

Pre-market Notification Details

Device IDK961272
510k NumberK961272
Device Name:NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
ContactGary Reasoner
CorrespondentGary Reasoner
NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
Product CodeLOS
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-02
Decision Date1996-11-01
Summary:summary

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