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

    ACTIVE MODEL CIC

    K Number: K945218 · Decision Dec 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    ACTIVE MODEL CIC
    K Number
    K945218
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Active Electronics, Inc.
    Date Received
    October 26, 1994
    Decision Date
    December 21, 1994
    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
    K910700 ACTIVE MODEL AST CUSTOM ITE HEARING AID
    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
    K910701 ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
    K910705 ACTIVE MODEL AHX HELIX ITE HEARING AID