BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CLEWICU System (ClewICUServer and ClewICUnitor)

    K Number: K200717 · Decision Jan 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    297

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    Basic Information

    Device Name
    CLEWICU System (ClewICUServer and ClewICUnitor)
    K Number
    K200717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clew Medical , Ltd.
    Date Received
    March 18, 2020
    Decision Date
    January 9, 2021
    Product Code
    QNL
    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
    QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator

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    Other Clearances by Clew Medical , Ltd.

    K Number Device Name
    K233216 CLEWICU System