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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
Original Applicant
DRAEGER MEDICAL, INC.
3135 quarry rd.
telford,  PA  18969
Original Contact michael a kelhart
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/07/2004
Decision Date 10/08/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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