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

    NEUROSTAT, LLOYD

    K Number: K781302 · Decision Aug 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    17
    Review Days
    18

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    Basic Information

    Device Name
    NEUROSTAT, LLOYD
    K Number
    K781302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Spembly Medical , Ltd.
    Date Received
    July 28, 1978
    Decision Date
    August 15, 1978
    Product Code
    GXH
    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
    GXH Device, Surgical, Cryogenic

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    Other Clearances by Spembly Medical , Ltd.

    K Number Device Name
    K925129 SELECTOR
    K903303 SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
    K901974 SELECTOR ULTRASONIC SURGICAL ASPIRATOR
    K882568 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
    K882962 SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
    K882963 SPEMBLY MEDICAL 142 CRYO UNIT
    K874367 VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
    K840497 OBSTETRIC PULSAR TWO CHANNEL TENS
    K832385 CRYOPROBES MC-1400-CRYOSURG-CONSOLE
    K832334 CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
    Search all 17 clearances from Spembly Medical , Ltd. →