MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Models Wep-8410a And Wep-8420a Telemetry Central.

Pre-market Notification Details

Device IDK901034
510k NumberK901034
Device Name:MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
ContactMike Dashefsky
CorrespondentMike Dashefsky
NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-06
Decision Date1990-04-19

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