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510(k) K003905

ACTI-ICP MONITORING SYSTEM by Innerspace, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2001
Date Received
December 19, 2000
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

Other clearances by Innerspace, Inc.

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  • K072379 — MPS OXIPORT AND MPS OXIPORT PLUS (April 29, 2008)
  • K041838 — MPS (OR MPS-T) (March 1, 2005)
  • K013705 — ACT III VENTRICULAR CATHETER (September 9, 2002)
  • K013005 — ACT 11 MP VENTRICULAR CATHETER (March 8, 2002)
  • K010422 — ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER (June 28, 2001)

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