Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182543
    Device Name
    Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
    Manufacturer
    snap40 Ltd
    Date Cleared
    2018-11-14

    (58 days)

    Product Code
    MSX, BZQ, DQA, DRG, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    snap40 Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals. snap40 is intended to provide visual and audible physiologic multi-parameter alarms. snap40 is intended for temperature monitoring temperature at the upper arm is clinically indicated. snap40 continuously monitors the following parameters in adults: - · Pulse rate - · Oxygen saturation - · Temperature - · Movement snap40 is intended for intermittent or spot-check monitoring of respiration rate. snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor. snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
    Device Description
    snap40 consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. snap40 is intended to continuously monitor adult patient vital signs in non-critical areas of the hospital, mainly general medical/surgical units, across pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). snap40 is intended for intermittent or spot-checking monitoring of respiration rate (RESP).
    Ask a Question

    Page 1 of 1