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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 K920910
Device Name OXYGEN POWERED RESUSCITATOR FOR CPR
Applicant
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Applicant Contact GEORGE P EMERSON
Correspondent
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
Correspondent Contact GEORGE P EMERSON
Regulation Number868.5925
Classification Product Code
BTL  
Date Received02/27/1992
Decision Date 01/12/1993
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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