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510(k) K113088

HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) by Innerspace, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
October 19, 2011
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.

  • K083378 — SYNERGY (September 29, 2009)
  • 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)
  • K003905 — ACTI-ICP MONITORING SYSTEM (June 15, 2001)

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  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)