FDA 510(k) Application Details - K072008

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K072008
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant BRAEMAR, INC.
1285 CORPORATE CENTER DR.
SUITE 150
EAGAN, MN 55121 US
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Contact DARREN DERSHEM
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 07/23/2007
Decision Date 10/03/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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