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510(k) K141113

SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE by Spacelabs Healthcare, Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2014
Date Received
April 30, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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