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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 -1691
Applicant Contact GEORGE P EMERSON
Correspondent
J. H. EMERSON CO.
22 COTTAGE PARK AVE.
CAMBRIDGE,  MA  02140 -1691
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
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