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

    HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

    K Number: K211465 · Decision Jul 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    1
    Review Days
    58

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    Basic Information

    Device Name
    HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
    K Number
    K211465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lfesciences
    Date Received
    May 11, 2021
    Decision Date
    July 8, 2021
    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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