BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEARING AID VARIOUS MODELS

    K Number: K821972 · Decision Jul 20, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    9
    Review Days
    18

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    Basic Information

    Device Name
    HEARING AID VARIOUS MODELS
    K Number
    K821972
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Panasonic Co. Div. Matsu Elec. Corp. America
    Date Received
    July 2, 1982
    Decision Date
    July 20, 1982
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by Panasonic Co. Div. Matsu Elec. Corp. America

    K Number Device Name
    K860634 PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP
    K832076 ELECTRONIC BLOOD PRESS. METER EN-212
    K841103 NONINVASIVE BLOOD PRESSURE MEASURE SYS
    K833510 PANASONIC WH-50 HEARING AID
    K832075 ELECTRONIC BLOOD PRESS. METER-ZH-820P
    K831151 PANASONIC MODEL EW-213
    K831150 PANASONIC MODEL HV-5
    K823285 MODEL WHO1 HEARING AID