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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K941922
Device Name MEDSAT OXYGEN SATURATION SYSTEM
Applicant
Medtronic Bio-Medicus, Inc.
9600 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact ROBERTA THOMPSON
Correspondent
Medtronic Bio-Medicus, Inc.
9600 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact ROBERTA THOMPSON
Regulation Number870.4330
Classification Product Code
DRY  
Date Received04/20/1994
Decision Date 02/17/1995
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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