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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K862712
Device Name EMERSON MODEL 3HV COMPACT VENTILATOR
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 Number868.5895
Classification Product Code
CBK  
Date Received07/16/1986
Decision Date 09/18/1986
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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