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510(k) Data Aggregation

    K Number
    K974647
    Device Name
    FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1998-01-05

    (24 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633

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

    The surgical drape is used as a protective patient covering such as to isolate a side of surgical incision from microbial and other contamination.

    Device Description

    Fanfold Drape (Surgical Drape) 41"x57"

    AI/ML Overview

    The provided text is a letter from the FDA to Customed, Incorporated regarding their Fanfold Drape (Surgical Drape) - Product No. 900-633. This letter is a 510(k) clearance, indicating that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is solely a regulatory clearance document.

    Therefore, I cannot provide the requested information based on the input text. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is typically found in a detailed device validation report or a clinical study report, not in a 510(k) clearance letter.

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