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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
Applicant Contact EMERSON, VP
Correspondent
J. H. Emerson Co.
22 Cottage Park Ave.
Cambridge,  MA  02140
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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