FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON

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 Model/ds-1030a Dynascope Series Mon.

Pre-market Notification Details

Device IDK853213
510k NumberK853213
Device Name:FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
ClassificationDetector And Alarm, Arrhythmia
Applicant FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland ,  WA  98034 -
ContactDon Andresen
CorrespondentDon Andresen
FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland ,  WA  98034 -
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-20
Decision Date1985-10-11

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