BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Pressio 2 ICP Monitoring System

    K Number: K162108 · Decision Apr 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    9
    Review Days
    262

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    Basic Information

    Device Name
    Pressio 2 ICP Monitoring System
    K Number
    K162108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sophysa SA
    Date Received
    July 29, 2016
    Decision Date
    April 17, 2017
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Sophysa SA

    K Number Device Name
    K141227 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
    K091328 SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
    K090342 POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
    K062584 PRESSIO ICP MONITORING SYSTEM
    K042481 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
    K031097 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
    K013488 SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
    K992465 SOPHY SU8 PRESSURE ADJUSTABLE VALVE