FDA 510(k) Application Details - K091021

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K091021
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant IMETRIKUS, INC.
2141 LANDINGS DRIVE
MOUNTAIN VIEW, CA 94043 US
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Contact MICHAEL ACOSTA
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 04/09/2009
Decision Date 07/15/2009
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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