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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K852337
Device Name PNEUMOSCOPE
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 Number868.1840
Classification Product Code
BZG  
Date Received05/31/1985
Decision Date 07/01/1985
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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