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510(k) Data Aggregation

    K Number
    K121374
    Device Name
    ZI BLOWER
    Manufacturer
    DESHUM MEDICAL
    Date Cleared
    2013-02-22

    (291 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K100121,K052597,K013843
    Predicate For
    K140929
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZI blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.

    Device Description

    The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary for the Z1 Blower, detailing its acceptance criteria and the study that proves it meets those criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (If explicitly stated or inferred)Reported Device Performance
    Temperature at Patient Port
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