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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Ponto 5 Mini

    K Number: K211640 · Decision Aug 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    16
    Review Days
    75

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    Basic Information

    Device Name
    Ponto 5 Mini
    K Number
    K211640
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oticon Medical AB
    Date Received
    May 27, 2021
    Decision Date
    August 10, 2021
    Product Code
    LXB
    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
    LXB Hearing Aid, Bone Conduction

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    Other Clearances by Oticon Medical AB

    K Number Device Name
    K240614 Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
    K213733 Ponto 5 SuperPower
    K203807 Ponto Bone Anchored Hearing System, MONO Surgery Kit
    K190540 Ponto 4
    K161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
    K152820 Ponto Bone Anchored Hearing System
    K152067 Ponto bone anchored hearing system
    K142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
    K141616 STERILIZATION CASSETTE
    K132775 PONTO PLUS AND PONTO PLUS POWER
    Search all 16 clearances from Oticon Medical AB →