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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K940188
Device Name PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
Applicant
Biomedical Sensors, Ltd.
Short St., High Wycombe
Bucks.Hp11 2qh, England,  GB
Applicant Contact JAN WALTERS
Correspondent
Biomedical Sensors, Ltd.
Short St., High Wycombe
Bucks.Hp11 2qh, England,  GB
Correspondent Contact JAN WALTERS
Regulation Number868.1150
Classification Product Code
CCC  
Date Received01/13/1994
Decision Date 11/13/1995
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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