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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 K042086
Device Name FABIUS GS ANESTHESIA SYSTEM; 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 Received08/03/2004
Decision Date 08/31/2004
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
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