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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 K863410
Device Name PATIENT VALVE WITH AIR ENTRAINMENT
Applicant
Pneupac , Ltd.
Crescent Rd.
Luton Beds Lu2 Oah,  GB
Applicant Contact WEISS
Correspondent
Pneupac , Ltd.
Crescent Rd.
Luton Beds Lu2 Oah,  GB
Correspondent Contact WEISS
Regulation Number868.5925
Classification Product Code
BTL  
Date Received07/23/1986
Decision Date 01/12/1987
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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