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

    ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID

    K Number: K910701 · Decision Feb 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    1366
    Applicant Total
    7
    Review Days
    8

    Basic Information

    Device Name
    ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
    K Number
    K910701
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    ACTIVE ELECTRONICS, INC.
    Date Received
    February 20, 1991
    Decision Date
    February 28, 1991
    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 ACTIVE ELECTRONICS, INC.

    K Number Device Name
    K945218 ACTIVE MODEL CIC
    K910702 ACTIVE MODEL AHS HALF SHELL ITE HEARING AID
    K910704 ACTIVE MODEL AMC MINI CANAL ITE HEARING AID
    K910703 ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
    K910700 ACTIVE MODEL AST CUSTOM ITE HEARING AID
    K910705 ACTIVE MODEL AHX HELIX ITE HEARING AID