CLOUDEKG

Transmitters And Receivers, Electrocardiograph, Telephone

MAKROMED, INC.

The following data is part of a premarket notification filed by Makromed, Inc. with the FDA for Cloudekg.

Pre-market Notification Details

Device IDK130878
510k NumberK130878
Device Name:CLOUDEKG
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant MAKROMED, INC. 88 STILES ROAD Salem,  NH  03079
ContactBarry V Ashar
CorrespondentBarry V Ashar
MAKROMED, INC. 88 STILES ROAD Salem,  NH  03079
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-29
Decision Date2014-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04650075330081 K130878 000

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