FDA 510(k) Application Details - K093134

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K093134
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant CERNER CORP.
2800 ROCKCREEK PKWY.
KANSAS CITY, MO 64117 US
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Contact SHELLEY S LOOBY
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 10/05/2009
Decision Date 11/27/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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