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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 K983198
Device Name TRENDCARE CALIBRATOR MODEL SCU 7007
Applicant
Diametrics Medical, Ltd.
Short St.
High Wycombe, Buckinghamshire,  GB HP11 2QH
Applicant Contact JAN WALTERS
Correspondent
Diametrics Medical, Ltd.
Short St.
High Wycombe, Buckinghamshire,  GB HP11 2QH
Correspondent Contact JAN WALTERS
Regulation Number868.1150
Classification Product Code
CCC  
Date Received09/11/1998
Decision Date 11/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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