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510(k) Data Aggregation

    K Number
    K963136
    Device Name
    PACER MODEL 100 INFUSION CONTROLLER
    Manufacturer
    HEALTH WATCH, INC.
    Date Cleared
    1997-10-10

    (423 days)

    Product Code
    LDR
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH WATCH, INC.

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

    The Pacer Model 100 Infusion Controller is indicated for use in:

      1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36" of water) is not required.
      1. The delivery of intravenous drugs where positive pressure (above 36" of water) is not required.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Pacer Model 100 Infusion Controller." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

    The letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.

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