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510(k) Data Aggregation

    K Number
    K002787
    Device Name
    MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
    Manufacturer
    PALCO LABS, INC.
    Date Cleared
    2000-11-29

    (83 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALCO LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K994372
    Device Name
    MODEL 120
    Manufacturer
    PALCO LABS, INC.
    Date Cleared
    2000-04-28

    (123 days)

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

    PALCO LABS, INC.

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

    The Model 120 is intended to be used in the hospital, doctor's office, emergency medical facilities, or home care environments to measure %SpO2 and heart rate. The Model 120 is intended for use in short-term monitoring on adults and children.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indications For Use" statement. It does not include acceptance criteria, study details, performance data, or information regarding ground truth, sample sizes, or expert qualifications. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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