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510(k) K093633

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE by Draegerwerk AG & CO Kgaa — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2010
Date Received
November 23, 2009
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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