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510(k) Data Aggregation

    K Number
    K972731
    Device Name
    NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1997-09-29

    (69 days)

    Product Code
    KDJ
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET

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

    A disposable, manual, peritoneal dialysis administration set for Neonatal patients only.

    Device Description

    Neo-Care Peritoneal Dialysis Adminstration Set

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Neo-Care Peritoneal Dialysis Administration Set) and an "Indications for Use Statement."

    This document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory communication stating that the device is substantially equivalent to a previously marketed device and can therefore be marketed.

    Therefore, I cannot provide the requested information based on the input text. The questions you've asked (about sample size, ground truth, expert qualifications, etc.) are related to performance studies, which are not detailed in this regulatory document.

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