K Number
K003905
Device Name
ACTI-ICP MONITORING SYSTEM
Manufacturer
Date Cleared
2001-06-15

(178 days)

Product Code
Regulation Number
882.1620
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information

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§ 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).

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