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510(k) Data Aggregation

    K Number
    K123308
    Device Name
    PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
    Manufacturer
    ALBAHEALTH, L.L.C.
    Date Cleared
    2013-02-08

    (107 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALBAHEALTH, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Pulstar Logix Intermittent Pneumatic Compression System
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