FDA 510(k) Application Details - K113372

Device Classification Name

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510(K) Number K113372
Device Name NUVANT, MOBILC CARDIAC TELEMETRY
Applicant CORVENTIS, INC.
1410 ENERGY PARK DRIVE
SUITE 1
Saint Paul, MN 55108 US
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Contact KATHLEEN LUNDBERG
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Regulation Number

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Classification Product Code QYX
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Date Received 11/16/2011
Decision Date 03/07/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K113372


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