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

    INTREX

    K Number: K833241 · Decision Oct 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    INTREX
    K Number
    K833241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pennwalt Corp.
    Date Received
    August 22, 1983
    Decision Date
    October 28, 1983
    Product Code
    EAP
    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
    EAP Unit, X-Ray, Intraoral

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