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

    OTOMAG BONE CONDUCTION HEARING SYSTEM

    K Number: K100193 · Decision May 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    5
    Review Days
    116

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    Basic Information

    Device Name
    OTOMAG BONE CONDUCTION HEARING SYSTEM
    K Number
    K100193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sophono, Inc.
    Date Received
    January 22, 2010
    Decision Date
    May 18, 2010
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.

    Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

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    Other Clearances by Sophono, Inc.

    K Number Device Name
    K153391 Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
    K132189 OTOMAG BONE CONDUCATION HEARING SYSTEM
    K123962 OTOMAG BONE CONDUCTION HEARING SYSTEM
    K102199 OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)