FDA 510(k) Application Details - K071953

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K071953
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant RTX HEALTHCARE A/S
STROEMMEN 6
NOERRESUNDBY DK-9400 DK
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Contact NIELS O ANDERSON
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 07/16/2007
Decision Date 08/08/2007
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



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