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

    SPI-SECRET PERSONAL INSTRUMENT CIC

    K Number: K952986 · Decision Aug 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    12
    Review Days
    40

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    Basic Information

    Device Name
    SPI-SECRET PERSONAL INSTRUMENT CIC
    K Number
    K952986
    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
    Midwest City Hearing Aid Center
    Date Received
    June 28, 1995
    Decision Date
    August 7, 1995
    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 Midwest City Hearing Aid Center

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    K953728 RX12 LINEAR FULL SHELL AND IN THE CANAL
    K953729 K AMP FULL SHELL AND IN THE EAR
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    K953038 DYNAMIC EQ/CLASS D
    K952821 MWCHAC 95 FS 12345
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    Search all 12 clearances from Midwest City Hearing Aid Center →