BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    RAUMEDIC ICP MONITORING SYSTEM

    K Number: K112017 · Decision Oct 11, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    6
    Review Days
    89

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    Basic Information

    Device Name
    RAUMEDIC ICP MONITORING SYSTEM
    K Number
    K112017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Raumedic AG
    Date Received
    July 14, 2011
    Decision Date
    October 11, 2011
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    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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    Pressio 3 Multi-parameter Neuromonitoring System

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    NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

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    Other Clearances by Raumedic AG

    K Number Device Name
    K250285 NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
    K171666 MPR2 logO DATALOGGER
    K130529 RAUMEDIC-PTO-MONITORING-SYSTEM
    K120252 RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
    K103206 RAUMEDIC- ICP-MONITORING SYSTEM