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FDA 510(k) Application Details - K151672
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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