FDA 510(k) Application Details - K151672

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K151672
Device Name System,Network And Communication,Physiological Monitors
Applicant CERNER CORPORATION
2800 ROCKCREEK PKWY.
KANSAS CITY, MO 64117 US
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Contact SHELLEY S. LOOBY
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 06/22/2015
Decision Date 12/21/2015
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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