FUKUDA DENSHI MODEL LX-3100

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 Lx-3100.

Pre-market Notification Details

Device IDK903514
510k NumberK903514
Device Name:FUKUDA DENSHI MODEL LX-3100
ClassificationDetector And Alarm, Arrhythmia
Applicant FUKUDA DENSHI USA, INC. 7102 180TH.AVENUE N.E.BLDG.A- STE.101 Redmond,  WA  98052
ContactRobert J Steurer
CorrespondentRobert J Steurer
FUKUDA DENSHI USA, INC. 7102 180TH.AVENUE N.E.BLDG.A- STE.101 Redmond,  WA  98052
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-03
Decision Date1991-01-30

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