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510(k) K083050

EVITE XL by Draeger Medical AG & Co. KG — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2008
Date Received
October 14, 2008
Clearance Type
Special
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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