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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K853922
Device Name PLOTTER FOR AS-500
Applicant
Riko Medical & Scientific Instrument Corp.
3000 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact NORMAN KANESAKA
Correspondent
Riko Medical & Scientific Instrument Corp.
3000 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact NORMAN KANESAKA
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/23/1985
Decision Date 11/14/1985
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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