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FDA 510(k) Application Details - K093134
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2910
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Classification Product Code
DRG
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More FDA Info for this Product Code
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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