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510(k) K110779

SPACELABS SMART DISCLOSURE SYSTEM by Spacelabs Healthcare — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2011
Date Received
March 21, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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