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

    ORCA (tm) - Operational Rescue Containment Apparatus

    K Number: K163223 · Decision Nov 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    351

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    Basic Information

    Device Name
    ORCA (tm) - Operational Rescue Containment Apparatus
    K Number
    K163223
    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
    November 16, 2016
    Decision Date
    November 2, 2017
    Product Code
    LGM
    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
    LGM Chamber, Patient Isolation

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    Other Clearances by Isovac Products, LLC

    K Number Device Name
    K052798 CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C