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510(k) Data Aggregation

    K Number
    K012276
    Device Name
    TEMP 3
    Manufacturer
    MEDICAL SOLUTIONS, INC.
    Date Cleared
    2001-08-20

    (32 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K060851,K091336
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THE WEDICAL SOLUTIONS, INC TEMP 3 WARMING CABINET IS DESIGNED TO STORE, REPIDLY HARM AND MAINTAIN TERRERATURE OF I.V. FLUID BAGS AND IRRIGATION BAGS PRIOR TO TICK TO THE IDE.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a letter from the FDA regarding a 510(k) premarket notification for a medical device called "TEMP 3" and the "Indications For Use" statement.

    This document does not contain information about acceptance criteria, device performance, sample sizes for testing or training, data provenance, expert qualifications, ground truth establishment, or any studies conducted. It is a regulatory notification confirming substantial equivalence to a predicate device for marketing purposes.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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