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510(k) Data Aggregation
K Number
K121573Device Name
INTEGRA CAMINO ICP MONITOR
Manufacturer
INTRGRA LIFESCIENCES CORPORATION
Date Cleared
2012-09-10
(104 days)
Product Code
GWM
Regulation Number
882.1620Why did this record match?
Applicant Name (Manufacturer) :
INTRGRA LIFESCIENCES CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
Device Description
The Integra® Camino® ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra fiberoptic and strain gauge catheters.
The Integra Camino ICP Monitor displays both ICP and temperature in numeric format. The device also displays real-time ICP waveform data. It will store the mean ICP trend data from the most recent 5 days. The user can elect to extract the ICP trend data stored on the Monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.
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