Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031086
    Device Name
    CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
    Date Cleared
    2003-05-14

    (37 days)

    Product Code
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEURO SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Camino® SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.
    Device Description
    The SPM-1 is an intracranial pressure monitor which features continuous mean Intracranial Pressure (ICP) display, high ICP alarm, and bedside monitor capabilities. The SPM-1 is a modified MPM-1 ICP monitor. It contains the same circuit boards as the MPM-1 but with fewer components, based on the scaled down features (no waveform display, temperature monitoring or ability to calculate CPP). The SPM-1 is supplied with a PAC-2 Pre-Amp Cable, and a PMIO-SPM Patient Monitor Cable. Non-sterile adapter cables (REF ICP-XX) are used to interface the PMIO-SPM cable to specific bedside monitors. These non-sterile cables come in many configurations, which facilitate data transfer between the PMIO-SPM cable and a specific brand of external bedside monitor. The following Camino® 110-4 Series ICP catheters are intended to be used with the SPM-1: 110-4B (Ventricular Bolt Pressure Monitoring Kit), 110-4G (Post Craniotomy Subdural Pressure Monitoring Kit), 110-4HM (Micro Ventricular Bolt Pressure Monitoring Kit), and 110-4L (Intracranial Pressure Monitoring Catheter with Licox® IMC Bolt Fitting). The use of temperature catheters is not recommended with the SPM-1.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1