Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210924
    Device Name
    e-Celsius Medical System
    Manufacturer
    Date Cleared
    2023-06-28

    (821 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BodyCAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    e-Celsius Medical System is indicated for the measurement of core body temperature in patients for whom accurate continuous core body temperatures are clinically necessary for periods exceeding six (6) hours and with whom rectal catheters are not appropriate. e-Celsius Medical System can only be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of and ingestible thermometer and determined that the risk is clinically justified versus an oral thermometer or- rectal catheter. e-Celsius Medical System is indicated for patients 18 years or older as long as their body weight is above 80 pounds. e-Celsius Medical System is not indicated for patients with special needs, esophageal or swallowing disorders, who are psychologically unsound, or have disabilities which may make the patient unable to swallow the device for any reason, these patients should be deemed ineligible for this device. e-Celsius Medical System is a prescription use device primarily (e.g., initial setup, final data assessment, reprocessing, etc.) indicated for use in clinical environments (e.g., hospitals, hospice, clinics, medical offices.)
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1