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510(k) K082600

OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) by Draeger Medical B.V. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2008
Date Received
September 8, 2008
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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