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FDA 510(k) Application Details - K152881
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K152881
Device Name
Computer, Diagnostic, Programmable
Applicant
SPACELABS HEALTHCARE LTD.
1 HARFORDE COURT
JOHN TATE ROAD
HERTFORD SG13 7NW GB
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Contact
AL VAN HOUDT
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
09/30/2015
Decision Date
04/01/2016
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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