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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K853443
Device Name ALVEO-DIFFUSION TEST
Applicant
Erich Jaeger, Inc.
5251 Zenith Pkwy.
Rockford,  IL  61111
Applicant Contact RONALD EVENSON
Correspondent
Erich Jaeger, Inc.
5251 Zenith Pkwy.
Rockford,  IL  61111
Correspondent Contact RONALD EVENSON
Regulation Number868.1880
Classification Product Code
BZC  
Date Received08/16/1985
Decision Date 02/21/1986
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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