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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 K062267
Device Name OXYLOG 3000
Applicant
DRAGER MEDICAL B.V.
3135 Quarry Road
Telford,  PA  18969
Applicant Contact BRYAN OVERTON
Correspondent
DRAGER MEDICAL B.V.
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact BRYAN OVERTON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/04/2006
Decision Date 10/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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