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

    BIO-LOGIC ABAER CUB

    K Number: K021215 · Decision May 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    45
    Review Days
    28

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    Basic Information

    Device Name
    BIO-LOGIC ABAER CUB
    K Number
    K021215
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Logic Systems Corp.
    Date Received
    April 17, 2002
    Decision Date
    May 15, 2002
    Product Code
    GWJ
    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
    GWJ Stimulator, Auditory, Evoked Response

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    Other Clearances by Bio-Logic Systems Corp.

    K Number Device Name
    K122496 AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
    K121512 SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
    K073626 BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
    K061744 COCHLEA-SCAN / COCHLEA-SCAN PLUS
    K052066 CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
    K031352 BIO-LOGIC INSERT EARPHONES
    K030907 STACKED ABR FOR NAVIGATOR PRO
    K031009 MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
    K021895 BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
    K021801 BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
    Search all 45 clearances from Bio-Logic Systems Corp. →