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510(k) Data Aggregation

    K Number
    K181165
    Device Name
    Philips wearable biosensor-G5 Solution
    Manufacturer
    Connected Sensing- A Division of Philips Medical Systems
    Date Cleared
    2019-03-07

    (309 days)

    Product Code
    DRT, DRX, MHX
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Connected Sensing- A Division of Philips Medical Systems

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in noncritical hospital settings. The Philips wearable biosensor-G5 solution is used as a higher resolution heart rate log by nurses or physicians retrospectively as an aid in making non-ife threatening therapeutic decisions. The biosensor is intended for patients who are 18 years of age or older. The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).
    Device Description
    Philips wearable biosensor-G5 Solution is a physiological sensing solution that gathers and stores a patient's heart rate. Philips wearable biosensor-G5 Solution is comprised of the: - Philips wearable biosensor-G5 - and data visualization application "G5 application" ● The Philips wearable biosensor-G5 is a battery operated, single-use device, measuring heart rate by continuously acquiring surface electrical waveforms related to cardiac excitations and measuring beat-to-beat intervals when a patient is stationary or ambulatory. The sensor functions by capturing and then sending physiological data wirelessly to the software application. The sensor's frequency of data collection and transmission is configurable. The G5 application receives and displays data from the Philips wearable biosensor-G5 providing a user interface and exportable file for retrospective review and analysis.The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).
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