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FDA 510(k) Application Details - K110779
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K110779
Device Name
Computer, Diagnostic, Programmable
Applicant
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND, CO 80466 US
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Contact
THOMAS KROENKE
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
03/21/2011
Decision Date
04/19/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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