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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plethysmograph, Pressure
510(k) Number K843851
Device Name BODYSCREEN II
Applicant
Erich Jaeger, Inc.
P.O. Box 10008
Rockford,  IL  61131
Applicant Contact RONALD EVENSON
Correspondent
Erich Jaeger, Inc.
P.O. Box 10008
Rockford,  IL  61131
Correspondent Contact RONALD EVENSON
Regulation Number868.1750
Classification Product Code
CCM  
Date Received10/01/1984
Decision Date 02/14/1985
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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