LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061379
    Device Name
    INFINITY TELESMART TELEMETRY SYSTEM
    Manufacturer
    Draeger Medical Systems, Inc.
    Date Cleared
    2007-02-16

    (275 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K024108,K051658
    Why did this record match?
    Device Name :

    INFINITY TELESMART TELEMETRY SYSTEM

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

    Not Found

    Device Description

    The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is derived from miniaturization of the INFINITY ALPHA patient monitor. This new device performs telemetry monitoring of ambulatory and non-ambulatory patients, using the same algorithms that are incorporated in the INFINITY ALPHA.

    AI/ML Overview

    The provided text is a truncated 510(k) summary for the "Infinity TeleSmart Telemetry System." It does not contain the necessary information to answer your request regarding acceptance criteria, device performance, and study details. The document explicitly states:

    • "Assessment of non-clinical performance data for equivalence: Refer to section 10"
    • "Assessment of clinical performance data for equivalence: Was not generated for this submission"

    Without access to "section 10" and with the statement that clinical performance data was not generated, I cannot extract the specific details you've asked for. The summary primarily focuses on identifying the device, its classification, and predicate devices, along with indicating that it uses the same algorithms as a previously cleared device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1