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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K802168
Device Name DRAGER AV2 ANESTHESIA VENTILATOR
Applicant
DRAEGER MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DRAEGER MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/08/1980
Decision Date 12/20/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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