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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 K103625
Device Name OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
Applicant
Draeger Medical Systems, Inc.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
Draeger Medical Systems, Inc.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
BTL  
Date Received12/10/2010
Decision Date 10/06/2011
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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