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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 K881808
Device Name EMERSON CHEST RESPIRATOR, MODEL 33-CRE
Applicant
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140 -1691
Applicant Contact EMERSON, VP
Correspondent
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140 -1691
Correspondent Contact EMERSON, VP
Regulation Number868.5935
Classification Product Code
BYT  
Date Received04/28/1988
Decision Date 08/04/1988
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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