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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K082600
Device Name OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
Applicant
Draeger Medical B.V.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
Draeger Medical B.V.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/08/2008
Decision Date 11/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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