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FDA 510(k) Application Details - K153654
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K153654
Device Name
Computer, Diagnostic, Programmable
Applicant
CareFusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg 97204 DE
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Contact
Elmar Niedermeyer
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2015
Decision Date
09/16/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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