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

    FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

    K Number: K243966 · Decision Apr 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
    K Number
    K243966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Faceheart Corp.
    Date Received
    December 23, 2024
    Decision Date
    April 9, 2025
    Product Code
    BZQ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZQ Monitor, Breathing Frequency

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    Other Clearances by Faceheart Corp.

    K Number Device Name
    K223622 FaceHeart Vitals Software Development Kit (FH vitals SDK)