FDA 510(k) Application Details - K101242

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K101242
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant HONEYWELL HOMMED, LLC
3400 INTERTECH DR.
SUITE 200
BROOKFIELD, WI 53045 US
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Contact EMILY HEI
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 05/03/2010
Decision Date 06/11/2010
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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