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

    PENTAX FACE MASK

    K Number: K933683 · Decision Jun 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    67
    Review Days
    673

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    Basic Information

    Device Name
    PENTAX FACE MASK
    K Number
    K933683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    July 29, 1993
    Decision Date
    June 2, 1995
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FXX Mask, Surgical

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    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
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    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023376 EB-1830T3, VIDEO BRONCHOSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
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