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510(k) Data Aggregation

    K Number
    K111617
    Device Name
    PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
    Manufacturer
    ACARE TECHNOLOGY CO., LTD.
    Date Cleared
    2011-12-22

    (195 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1

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

    Finger Type Pulse Oximeter, AB-F1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult patients use.

    Handheld Pulse Oximeter, AH-S1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.

    Handheld Pulse Oximeter, AH-M1 is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is limited to the FDA 510(k) clearance letter and Indications for Use statements for three pulse oximeters (AB-F1, AH-S1, and AH-M1). It confirms that the devices are substantially equivalent to previously marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria or the specifics of a study proving device performance against those criteria. This type of detailed study information (performance data, sample sizes, ground truth establishment, expert qualifications, etc.) is typically found in the 510(k) submission's safety and effectiveness section, which is not part of this publicly available clearance letter.

    Therefore, I cannot extract the requested information from the provided text. I can only confirm that:

    • Device Names: Finger Type Pulse Oximeter, AB-F1; Handheld Pulse Oximeter, AH-S1; Handheld Pulse Oximeter, AH-M1
    • Intended Use: Spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital type facilities and home care environment.
    • Patient Population: AB-F1 for adult patients. AH-S1 and AH-M1 for adult, pediatric, and neonatal patients.
    • Regulatory Status: Substantially equivalent (510(k) K111617) to a predicate device.
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