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

    DR. FOG

    K Number: K932449 · Decision Aug 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    34
    Review Days
    83

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    Basic Information

    Device Name
    DR. FOG
    K Number
    K932449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    O.R. Concepts, Inc.
    Date Received
    May 20, 1993
    Decision Date
    August 11, 1993
    Product Code
    OCT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCT Anti Fog Solution And Accessories, Endoscopy

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    K922244 INSUFFLATOR TUBING/FILTER KIT
    K922197 INSUFFLATOR TUBING KIT
    K925147 ORC 10.0MM SUCTION PROBE
    K925024 ORC TAPPERED IRRIGATING PROBE
    K923908 # 9455 AND #9457 POOLE TIP SUCTION PROBE
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