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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K961661
Device Name OXIMETRIX 4 COMPUTER SYSTEM
Applicant
Abbott Laboratories
Dept. 389, Ap30
Abbott Park,  IL  60064
Applicant Contact DAVID GUZEK
Correspondent
Abbott Laboratories
Dept. 389, Ap30
Abbott Park,  IL  60064
Correspondent Contact DAVID GUZEK
Regulation Number870.1435
Classification Product Code
DXG  
Date Received04/30/1996
Decision Date 03/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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