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510(k) Data Aggregation

    K Number
    K955497
    Device Name
    GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
    Manufacturer
    COBE RENAL CARE, INC.
    Date Cleared
    1997-09-25

    (664 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET

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

    Not Found

    Device Description

    Gambro FH 22H Fiber Hemofilter

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Gambro FH 22H Fiber Hemofilter). It primarily states that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, nor any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth, training set information).

    This type of FDA letter confirms regulatory clearance based on substantial equivalence, but it typically summarizes the outcome of the review process, not the detailed performance data or study specifics submitted by the manufacturer. The detailed studies and data would be part of the original 510(k) submission, which is not included here.

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