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

    DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM

    K Number: K944162 · Decision Nov 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    95

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    Basic Information

    Device Name
    DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM
    K Number
    K944162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1830
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teledyne Water Pik
    Date Received
    August 26, 1994
    Decision Date
    November 29, 1994
    Product Code
    EAG
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EAG Cephalometer

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