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510(k) K113051

SPACELABS ARKON ANESTHESIA WORKSTATION by Spacelabs Healthcare — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2012
Date Received
October 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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