FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR

Detector And Alarm, Arrhythmia

FUKUDA DENSHI USA, INC.

The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope Model Ds-5800 Central Station Monitor.

Pre-market Notification Details

Device IDK970585
510k NumberK970585
Device Name:FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
ClassificationDetector And Alarm, Arrhythmia
Applicant FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond,  WA  98052 -4911
ContactDavid J Geraghty
CorrespondentDavid J Geraghty
FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond,  WA  98052 -4911
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-14
Decision Date1997-09-09
Summary:summary

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