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510(k) Data Aggregation

    K Number
    K972528
    Manufacturer
    Date Cleared
    1997-07-28

    (21 days)

    Product Code
    Regulation Number
    880.6910
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)

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

    The Dyna GLIDE 2600 Roll-in Ambulance Cot is a PROFESSIONAL USE ONLY patient handling device with designed features allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose of the Dyna GLIDE 2600 is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Dyna GLIDE 2600 Roll-In Ambulance Cot." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study design, or performance data of the device itself.

    Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria, as it is not present in the given text.

    The information I can extract from the document is related to the device's regulatory approval:

    • Device Name: Dyna GLIDE 2600 Roll-In Ambulance Cot
    • Intended Use: A PROFESSIONAL USE ONLY patient handling device with designed features allowing the Cot to be easily rolled in and out of an ambulance patient compartment. The primary purpose is to ease the medical movement of a patient in an emergency medical situation by qualified and trained Emergency Medical Technicians (EMT)/Attendants.
    • Regulatory Class: II
    • Premarket Notification Number: K972528 (though it is K972538 at the bottom of page 2)
    • Approval Date: July 28, 1997
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