FDA 510(k) Application Details - K130360

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K130360
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant CONSTANT CARE, LLC
1300 I ST, NW, 11TH FLOOR EAST
WASHINGTON, DC 20005-3314 US
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Contact SETH A MAILHOT
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 02/13/2013
Decision Date 07/15/2013
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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