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K Number
K010422
Device Name
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
Manufacturer
INNERSPACE, INC.
Date Cleared
2001-06-28

(136 days)

Product Code
GWM
Regulation Number
882.1620
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).