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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 K924343
Device Name WRIGHT POCKET PEAK FLOW METER
Applicant
Ferraris Medical, Inc.
P.O. Box 344
Holland,  NY  14080
Applicant Contact DAVID R MALYS
Correspondent
Ferraris Medical, Inc.
P.O. Box 344
Holland,  NY  14080
Correspondent Contact DAVID R MALYS
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/27/1992
Decision Date 06/16/1993
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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