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510(k) Data Aggregation

    K Number
    K121712
    Date Cleared
    2012-11-20

    (162 days)

    Product Code
    Regulation Number
    870.2300
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AIRSTRIP RPM FOR LIFENET CONSULT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AirStrip RPM for LIFENET Consult is an optional data transmission system that provides the capability to receive notifications at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for the AirStrip Remote Patient Monitoring (RPM) for LIFENET® Consult device. Unfortunately, the provided document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    This type of FDA letter typically confirms that a device is substantially equivalent to a predicate device and is cleared for marketing. It usually does not include the detailed scientific study results that demonstrate how the device meets specific performance acceptance criteria. Such information would typically be found in the original 510(k) submission, which is a much more extensive document.

    Therefore, I cannot provide the requested table and study details.

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