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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 K832176
Device Name NEGATIVE PRESSURE CHEST RESPIRATOR PUMP
Applicant
J. H. Emerson Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
J. H. Emerson Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5935
Classification Product Code
BYT  
Date Received07/06/1983
Decision Date 09/12/1983
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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