NETKONNECT REMOTE NETWORK EXTENSION

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

NIHON KOHDEN

The following data is part of a premarket notification filed by Nihon Kohden with the FDA for Netkonnect Remote Network Extension.

Pre-market Notification Details

Device IDK112637
510k NumberK112637
Device Name:NETKONNECT REMOTE NETWORK EXTENSION
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant NIHON KOHDEN 90 ICON Foothill Ranch,  CA  92610
ContactSteve Geerdes
CorrespondentSteve Geerdes
NIHON KOHDEN 90 ICON Foothill Ranch,  CA  92610
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-09
Decision Date2011-12-09
Summary:summary

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