Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring System

• • Terminated Z-1191-2008 FDA Unclassified (pre-2012) ·initiated 28 Jan 2008

  Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg.

510(k) Number

K071505 ↗

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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  Class I

  CE/MDR

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