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510(k) K101850

SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION by Spacelabs Healthcare, Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2011
Date Received
July 1, 2010
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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