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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K980380
Device Name NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
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 Number882.1620
Classification Product Code
GWM  
Date Received02/02/1998
Decision Date 07/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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