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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 K944397
Device Name BNOS MICROVENT, MODEL AC AND MODEL AO
Applicant
Racal Health & Safety, Inc.
7305 Executive Way
Frederick,  MD  21701
Applicant Contact YUK-TING WU
Correspondent
Racal Health & Safety, Inc.
7305 Executive Way
Frederick,  MD  21701
Correspondent Contact YUK-TING WU
Regulation Number868.5925
Classification Product Code
BTL  
Date Received09/08/1994
Decision Date 01/31/1995
Decision Substantially Equivalent - Kit (SESK)
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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