FDA 510(k) Application Details - K040966

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K040966
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant CAREMATIX INC.
2 N. LASALLE ST.
SUITE 1805
CHICAGO, IL 60602 US
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Contact SUKHWANT KHANUJA
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 04/14/2004
Decision Date 06/02/2004
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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