HEARTRAK SMART AT/HEARTRAK SMART2

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 Smart At/heartrak Smart2.

Pre-market Notification Details

Device IDK033451
510k NumberK033451
Device Name:HEARTRAK SMART AT/HEARTRAK SMART2
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant UNIVERSAL MEDICAL, INC. ONE COMMERCE SQUARE 2005 MARKET STREET, SUITE 2340 Philadelphia,  PA  19103
ContactDouglas M Lurio
CorrespondentDouglas M Lurio
UNIVERSAL MEDICAL, INC. ONE COMMERCE SQUARE 2005 MARKET STREET, SUITE 2340 Philadelphia,  PA  19103
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-30
Decision Date2004-02-05
Summary:summary

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