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

    GO-CLEAN

    K Number: K922110 · Decision Mar 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    673

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    Basic Information

    Device Name
    GO-CLEAN
    K Number
    K922110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viva-Tek Assoc., Inc.
    Date Received
    May 5, 1992
    Decision Date
    March 9, 1994
    Product Code
    FRR
    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
    FRR Chamber, Reverse Isolation, Patient Care

    Other Clearances by Viva-Tek Assoc., Inc.

    K Number Device Name
    K920043 AIRES