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

    CRITIVIEW, MODEL CRV3

    K Number: K062977 · Decision Feb 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    2
    Review Days
    152

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    Basic Information

    Device Name
    CRITIVIEW, MODEL CRV3
    K Number
    K062977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Critisense , Ltd.
    Date Received
    September 29, 2006
    Decision Date
    February 28, 2007
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Critisense , Ltd.

    K Number Device Name
    K051145 CRITIVIEW