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510(k) Data Aggregation

    K Number
    K141609
    Device Name
    PULSTAR LOGIX PUMP
    Manufacturer
    ALBAHEALTH LLC
    Date Cleared
    2014-07-15

    (29 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALBAHEALTH LLC

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

    Patients at Risk for DVT:
    These include:
    a. Major orthopedic procedures e.g. knee surgery
    Major abdominal thoracic surgery including urogenital surgery
    Neurosurgery, subarachnoid hemorrhage and stroke
    Bedridden Medical patients
    b. Patients with chronic venous insufficiency

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for a device called "Pulstar Logix Pump." It primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and administrative information. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    Therefore, I cannot fulfill your request for the specific details outlined concerning acceptance criteria and study findings. The document confirms the device's classification and regulatory path but does not delve into the technical performance studies that meet specific acceptance criteria.

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