HEARTRAK AF

Transmitters And Receivers, Electrocardiograph, Telephone

UNIVERSAL MEDICAL, INC.

The following data is part of a premarket notification filed by Universal Medical, Inc. with the FDA for Heartrak Af.

Pre-market Notification Details

Device IDK071130
510k NumberK071130
Device Name:HEARTRAK AF
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant UNIVERSAL MEDICAL, INC. 275 PHILLIPS BLVD. Ewing,  NJ  08618
ContactSteven Adamsky
CorrespondentSteven Adamsky
UNIVERSAL MEDICAL, INC. 275 PHILLIPS BLVD. Ewing,  NJ  08618
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-23
Decision Date2008-05-14
Summary:summary

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