ECARD AND CCARD

Transmitters And Receivers, Electrocardiograph, Telephone

IRHYTHM TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Ecard And Ccard.

Pre-market Notification Details

Device IDK081471
510k NumberK081471
Device Name:ECARD AND CCARD
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco,  CA  94103
ContactWilliam H Righter
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-05-27
Decision Date2008-06-24

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