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

    CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

    K Number: K011364 · Decision Jun 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    42
    Review Days
    34

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    Basic Information

    Device Name
    CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
    K Number
    K011364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Hearing Instruments, Inc.
    Date Received
    May 4, 2001
    Decision Date
    June 7, 2001
    Product Code
    KLW
    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
    KLW Masker, Tinnitus

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    Other Clearances by Siemens Hearing Instruments, Inc.

    K Number Device Name
    K071462 UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
    K011366 CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
    K003559 TCI (TINNITUS CONTROL INSTRUMENT)
    K003558 TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
    K972998 PRISMA
    K962170 SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP
    K952940 PERSONAL PROGRAMMER 2000
    K951828 FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
    K952263 PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
    K951896 INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
    Search all 42 clearances from Siemens Hearing Instruments, Inc. →