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

    HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

    K Number: K223127 · Decision Nov 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    3
    Review Days
    35

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    Basic Information

    Device Name
    HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
    K Number
    K223127
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifeciences, LLC
    Date Received
    October 3, 2022
    Decision Date
    November 7, 2022
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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