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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 K864379
Device Name EMERSON 3MV VOLUME 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 Received11/05/1986
Decision Date 12/15/1986
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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