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510(k) K031086

CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 by Integra Neurosciences — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2003
Date Received
April 7, 2003
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

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  • K020558 — LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE (March 21, 2002)
  • K002765 — LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTROD (November 24, 2000)

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