FDA 510(k) Application Details - K122095

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K122095
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant Emergo Europe Consulting BV
PRINSESSEGRACHT 20
DEN HAAG 2514 NL
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Contact RACHIDA ZIANI
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 07/12/2012
Decision Date 07/26/2012
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 Y
Expedited Review



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