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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 K041622
Device Name MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; 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
  View current 510(K) holder
Current 510(k) Holder *
Draegerwerk AG & Co. KGaA
53-55 MOISLINGER ALLEE
luebeck,  GERMANY  23542
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/16/2004
Decision Date 07/08/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No

 
* Reported through Establishment Registration and Device Listing
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