FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER

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-3240 Ecg & Respiratory Transmitter.

Pre-market Notification Details

Device IDK963057
510k NumberK963057
Device Name:FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
ClassificationDetector And Alarm, Arrhythmia
Applicant FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond,  WA  98052
ContactDavid J Geraghty
CorrespondentDavid J Geraghty
FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond,  WA  98052
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-06
Decision Date1997-03-21

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