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

    COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67

    K Number: K964821 · Decision Jul 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    226

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    Basic Information

    Device Name
    COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
    K Number
    K964821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ventrex, Inc.
    Date Received
    December 2, 1996
    Decision Date
    July 16, 1997
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQA Oximeter

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