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510(k) Data Aggregation

    K Number
    K040677
    Device Name
    COMBI SELF PROPELLED SHOWER COMMODE
    Manufacturer
    KJAERULFF REHABILITATION A/S
    Date Cleared
    2004-05-20

    (66 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Self- or attendant operated, self-propelled Shower Commode for use by hospitalised or disabled patients.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot provide the requested information.

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