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510(k) K162108

Pressio 2 ICP Monitoring System by Sophysa SA — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2017
Date Received
July 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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  • K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 (December 14, 2004)
  • K031097 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB (February 26, 2004)
  • K013488 — SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 (March 27, 2002)

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