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510(k) K112729

BLEASE700/900 SERIES VENTILATORS by Spacelabs Healthcare — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2012
Date Received
September 20, 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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