FDA 510(k) Application Details - K142743

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K142743
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant AliveCor, Inc.
30 Maiden Lane, 6th Floor
San Francisco, CA 94108 US
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Contact Albert Boniske
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 09/24/2014
Decision Date 01/27/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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