LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252448

    Validate with FDA (Live)

    Device Name
    AViTA Pulse Oximeter (SP61)
    Manufacturer
    Avita Corporation
    Date Cleared
    2026-02-27

    (207 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    K152563,K193350
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AViTA Pulse Oximeter is intended for spot check monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults, adolescents and child in home and professional healthcare facility settings. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches ~0.9 inches) and intended for use during no-motion condition. The device is prescription only

    Device Description

    The AViTA Pulse Oximeter is a non-invasive, prescription-use medical device intended for spot-check monitoring measurement of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate in adult, adolescent, and child users in home and professional healthcare environment settings.

    The device operates using spectrophotometry by emitting red and infrared light through a pulsatile vascular bed, such as a fingertip, and detecting the light transmitted through the tissue to determine the relative concentrations of oxygenated and deoxygenated hemoglobin.

    The device is designed for use on fingers with a thickness range of approximately 0.8 cm to 2.3 cm (0.3 inches to 0.9 inches) and is intended for use under no-motion conditions. The device is intended for spot-check measurements only and is not intended for continuous monitoring.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1