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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, external body, negative pressure, adult (cuirass)
510(k) Number K902764
Device Name EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
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 Number868.5935
Classification Product Code
BYT  
Date Received06/25/1990
Decision Date 11/19/1990
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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