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

    AUDIOMETER

    K Number: K870337 · Decision Apr 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    45
    Review Days
    78

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    Basic Information

    Device Name
    AUDIOMETER
    K Number
    K870337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Bio-Logic Systems Corp.
    Date Received
    January 28, 1987
    Decision Date
    April 16, 1987
    Product Code
    ETW
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

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    Other Clearances by Bio-Logic Systems Corp.

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    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
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