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510(k) Data Aggregation

    K Number
    K011779
    Device Name
    AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
    Manufacturer
    AVID CARE CORP.
    Date Cleared
    2001-07-13

    (36 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM

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

    The intended use for both the cleared and the modified Home Health Monitor System is for home use, patient operated:

      1. non-invasive blood pressure measurement.
      1. non-invasive blood oxygen saturation measurement using pulse oximetry,
      1. in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood, and
      1. patient weight using a stand-on electronic scale;

    and subsequent transmission of these measurements to a computer monitoring station in a clinical setting.

    Device Description

    Home Health Monitor System

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the AvidCare Series 100 Telemanagement System (also referred to as Home Health Monitor System). It determines substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to such a study.

    The document primarily focuses on the regulatory aspects of device clearance, stating its intended use and classification.

    Therefore, I cannot provide the requested information based on the given text.

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