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

    AHS OMEGA SP

    K Number: K970057 · Decision Feb 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    31
    Review Days
    50

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    Basic Information

    Device Name
    AHS OMEGA SP
    K Number
    K970057
    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
    Authorized Hearing Systems, Inc.
    Date Received
    January 7, 1997
    Decision Date
    February 26, 1997
    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 Authorized Hearing Systems, Inc.

    K Number Device Name
    K971693 RIONET HB-79P
    K963878 AHS OMEGA HF
    K963877 AHS OMEGA CONCEPT
    K963875 AHS OMEGA K-AMP
    K963874 AHS OMEGA AGC
    K963879 AHS DELTA 22
    K963873 AHS OMEGA DEQ
    K963881 AHS DELTA 22 T
    K963876 AHS OMEGA PP
    K963154 RIONET HB-54AS
    Search all 31 clearances from Authorized Hearing Systems, Inc. →