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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 K062584
Device Name PRESSIO ICP MONITORING SYSTEM
Applicant
Sophysa SA
2884 Danapoplar
Dana Point,  CA  92629
Applicant Contact ESTHER SALTZ
Correspondent
Sophysa SA
2884 Danapoplar
Dana Point,  CA  92629
Correspondent Contact ESTHER SALTZ
Regulation Number882.1620
Classification Product Code
GWM  
Date Received09/01/2006
Decision Date 07/05/2007
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
Recalls CDRH Recalls
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