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

    RETROX

    K Number: DEN020003 · Decision Aug 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    60

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RETROX
    K Number
    DEN020003
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    874.3950
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Auric Hearing Systems, Inc.
    Date Received
    June 21, 2002
    Decision Date
    August 20, 2002
    Product Code
    NIX
    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
    NIX Hearing Aid, Air Conduction, Transcutaneous System

    Similar 510(k) Clearances

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

    RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all