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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K951126
Device Name DRAGER MEDICAL AIR COMPRESSOR
Applicant
Drager, Inc.
4101-100 Pleasant Valley Rd.
Chantilly,  VA  22021
Applicant Contact HARALD KNEUER
Correspondent
Drager, Inc.
4101-100 Pleasant Valley Rd.
Chantilly,  VA  22021
Correspondent Contact HARALD KNEUER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received03/13/1995
Decision Date 03/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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