BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PARENCHYMAL BOLT PRESSURE MONITORING KIT

    K Number: K981846 · Decision Aug 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    3
    Review Days
    84

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PARENCHYMAL BOLT PRESSURE MONITORING KIT
    K Number
    K981846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Camino Neurocare, Inc.
    Date Received
    May 26, 1998
    Decision Date
    August 18, 1998
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GWM), ordered by most recent decision date.

    Pressio 3 Multi-parameter Neuromonitoring System

    FDA 510(k)
    FDA Class 2 ·Neurology

    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

    FDA 510(k)
    FDA Class 2 ·Neurology

    B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

    FDA 510(k)
    FDA Class 2 ·Neurology

    B4C System

    FDA 510(k)
    FDA Class 2 ·Neurology

    CereLink ICP Monitor

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Camino Neurocare, Inc.

    K Number Device Name
    K982702 VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
    K962928 COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)