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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 K972314
Device Name PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
Applicant
DIAMETRICS MEDICAL, LTD.
SHORT STREET
HIGH WYCOMBE, BUCKINGHAMSHIRE,  GB HP11 2QH
Applicant Contact KARIMA HEBRI
Correspondent
DIAMETRICS MEDICAL, LTD.
SHORT STREET
HIGH WYCOMBE, BUCKINGHAMSHIRE,  GB HP11 2QH
Correspondent Contact KARIMA HEBRI
Regulation Number868.1150
Classification Product Code
CCC  
Date Received06/20/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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