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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 K010793
Device Name OXYLOG 1000, MODEL 2M86840
Applicant
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/16/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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