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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K943797
Device Name BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER
Applicant
Bpr Medical, Ltd.
Oakham Business Park
Hamilton Way
Mansfield, Notts. England,  GB NG18 5BU
Applicant Contact RICHARD D RADFORD
Correspondent
Bpr Medical, Ltd.
Oakham Business Park
Hamilton Way
Mansfield, Notts. England,  GB NG18 5BU
Correspondent Contact RICHARD D RADFORD
Regulation Number868.5330
Classification Product Code
BZR  
Date Received08/03/1994
Decision Date 05/11/1995
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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