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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K042419
Device Name FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact MICHAEL A KELHART
Correspondent
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact MICHAEL A KELHART
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/07/2004
Decision Date 10/08/2004
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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