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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 K953893
Device Name PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
Applicant
Biomedical Sensors, Inc.
Short St.
High Wycombe, Buckinghamshire,  GB HP11 2QH
Applicant Contact KARIMA HEBRI
Correspondent
Biomedical Sensors, Inc.
Short St.
High Wycombe, Buckinghamshire,  GB HP11 2QH
Correspondent Contact KARIMA HEBRI
Regulation Number868.1150
Classification Product Code
CCC  
Date Received08/17/1995
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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