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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 K862192
Device Name RESUSCITATOR MODELS 10400/10500/10600/10700/10800
Applicant
U.O. Equipment Co.
P.O. Box 500386
Houston,  TX  77250
Applicant Contact R. R WRIGHT
Correspondent
U.O. Equipment Co.
P.O. Box 500386
Houston,  TX  77250
Correspondent Contact R. R WRIGHT
Regulation Number868.5925
Classification Product Code
BTL  
Date Received06/09/1986
Decision Date 07/07/1986
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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