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510(k) Data Aggregation

    K Number
    K981093
    Device Name
    WESCO BLANKET
    Manufacturer
    WESCO, INC.
    Date Cleared
    2000-03-28

    (733 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For Patient Temperature Management

    Device Description

    Wesco Blanket

    AI/ML Overview

    I am sorry, but the provided text is a set of FDA correspondence letters regarding a 510(k) clearance for a "Wesco Blanket," and an "Indications for Use" statement.

    This document does not contain information about:

    • Acceptance criteria for device performance
    • A study proving device meets acceptance criteria
    • Reported device performance statistics
    • Sample sizes for test or training sets
    • Data provenance
    • Number or qualifications of experts
    • Adjudication methods
    • MRMC comparative effectiveness studies or effect sizes
    • Standalone algorithm performance
    • Type of ground truth used

    Therefore, I cannot fulfill your request for these specific details. The document primarily confirms the substantial equivalence of the Wesco Blanket to a predicate device for patient temperature management, allowing it to be legally marketed.

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