TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH

Electrocardiograph

EATON MEDICAL GROUP

The following data is part of a premarket notification filed by Eaton Medical Group with the FDA for Telemetry Software For G-2000 Electrocardiograph.

Pre-market Notification Details

Device IDK850323
510k NumberK850323
Device Name:TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
Applicant EATON MEDICAL GROUP P.O. BOX 276 Eaton,  MI 
ContactPaul P Kluwe
CorrespondentPaul P Kluwe
EATON MEDICAL GROUP P.O. BOX 276 Eaton,  MI 
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-28
Decision Date1985-05-16

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