NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM

Detector And Alarm, Arrhythmia

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 Wep-8430a Central Telemetry System.

Pre-market Notification Details

Device IDK945944
510k NumberK945944
Device Name:NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
ContactPenni L Pannell
CorrespondentPenni L Pannell
NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-05
Decision Date1995-11-27

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