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510(k) Data Aggregation

    K Number
    K100203
    Device Name
    HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
    Manufacturer
    BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
    Date Cleared
    2010-05-17

    (112 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MD300A/MD300K2/MD300M handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

    Device Description

    Handheld Pulse Oximeter Model MD300A/ MD300K2/ MD300M

    AI/ML Overview

    This document is a 510(k) premarket notification letter for a Handheld Pulse Oximeter and does not contain the detailed study information required to fill out the table and answer all the questions. The letter confirms that the device is substantially equivalent to legally marketed predicate devices but does not include the actual performance data, acceptance criteria, or study design details.

    Therefore, I cannot provide the requested information from the given text. The relevant sections like "Acceptance criteria and the study that proves the device meets the acceptance criteria" are not present.

    The document only states the "Regulation Number: 21 CFR 870.2700" and "Regulation Name: Oscillometer" which would generally dictate the standards and required performance for such a device, but the specific acceptance criteria and study proving compliance are not detailed here.

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