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

    CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C

    K Number: K052798 · Decision Jun 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    246

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    Basic Information

    Device Name
    CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
    K Number
    K052798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isovac Products, LLC
    Date Received
    October 3, 2005
    Decision Date
    June 6, 2006
    Product Code
    LGN
    Advisory Committee
    General Hospital
    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
    LGN Chamber, Patient Transport Isolation

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