HL-300 RECEIVER MODULE

Electrocardiograph

FUKUDA DENSHI USA, INC.

The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Hl-300 Receiver Module.

Pre-market Notification Details

Device IDK915879
510k NumberK915879
Device Name:HL-300 RECEIVER MODULE
ClassificationElectrocardiograph
Applicant FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond,  WA  98052
ContactRobert J Steurer
CorrespondentRobert J Steurer
FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond,  WA  98052
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-30
Decision Date1992-01-27

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