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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K895791
Device Name OXYMAX
Applicant
Columbus Instruments Intl. Corp.
P.O. Box 44049
Columbus,  OH  43204
Applicant Contact JAN CZEKAJEWSKI
Correspondent
Columbus Instruments Intl. Corp.
P.O. Box 44049
Columbus,  OH  43204
Correspondent Contact JAN CZEKAJEWSKI
Regulation Number868.1730
Classification Product Code
BZL  
Date Received09/28/1989
Decision Date 03/28/1990
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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