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510(k) K072379

MPS OXIPORT AND MPS OXIPORT PLUS by Innerspace, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2008
Date Received
August 24, 2007
Clearance Type
Special
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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  • K083378 — SYNERGY (September 29, 2009)
  • 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)
  • K003905 — ACTI-ICP MONITORING SYSTEM (June 15, 2001)

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