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

    BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

    K Number: K011438 · Decision Jul 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    5
    Review Days
    74

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    Basic Information

    Device Name
    BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
    K Number
    K011438
    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
    Entific Medical Systems, Inc.
    Date Received
    May 10, 2001
    Decision Date
    July 23, 2001
    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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    FDA Class 2 ·Ear, Nose, Throat

    Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

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    Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

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    Other Clearances by Entific Medical Systems, Inc.

    K Number Device Name
    K042017 BAHA DIVINO
    K021837 BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
    K002913 HEADBAND FOR BAHA
    K992872 BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II