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

    INTRACRANIAL PRESSURE MONITORING KIT 070

    K Number: K853864 · Decision Feb 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    18
    Review Days
    156

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    Basic Information

    Device Name
    INTRACRANIAL PRESSURE MONITORING KIT 070
    K Number
    K853864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Camino Laboratories, Inc.
    Date Received
    September 17, 1985
    Decision Date
    February 20, 1986
    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 Camino Laboratories, Inc.

    K Number Device Name
    K932769 CAMINO VENTRICULAR DRAINAGE SYSTEM
    K930222 CAMINO VENTRICULAR ACCESS DEVICE
    K930221 CAMINO VENTRICULAR TRANSDUCER ACCESSORY
    K920088 CAMINO VENTRICULAR NEEDLE
    K914735 VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
    K912833 CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
    K893232 MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
    K881183 VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
    K863969 CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D
    K861961 CAMINO CSF DRAINAGE SYSTEM MODEL 040
    Search all 18 clearances from Camino Laboratories, Inc. →