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Combined Intracranial Pressure-Temperature Sensing System (Icp/)

by Camino Neurocare, Inc.

510(k) K962928

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962928 Date20 Dec 1996ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0602-2014 FDA Class II initiated 26 Nov 2013

    Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.

    • Terminated Z-0944-2012 FDA Unclassified (pre-2012) initiated 20 Oct 2011

    Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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