BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇾 Cayman Islands

    FaceHeart Vitals Software Development Kit (FH vitals SDK)

    K Number: K223622 · Decision Sep 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    FaceHeart Vitals Software Development Kit (FH vitals SDK)
    K Number
    K223622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2785
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Faceheart Corp.
    Date Received
    December 5, 2022
    Decision Date
    September 1, 2023
    Product Code
    QME
    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
    QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

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    Other Clearances by Faceheart Corp.

    K Number Device Name
    K243966 FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)