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    K Number
    K070235
    Device Name
    BODYGUARD PAIN MANAGER INFUSION SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2007-05-18

    (113 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BODYGUARD PAIN MANAGER INFUSION SYSTEM

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

    The BodyGuard infusion Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes, of administration, including intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

    Device Description

    The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the BodyGuard Infusion Pump System and primarily focuses on the regulatory approval and indications for use. It does not provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device.

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