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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 K072884
Device Name FABIUS MRI
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Applicant Contact KATHY ANDERSON
Correspondent
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact KATHY ANDERSON
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/09/2007
Decision Date 07/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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