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510(k) K152881

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM by Spacelabs Healthcare, Ltd. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2016
Date Received
September 30, 2015
Clearance Type
Traditional
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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