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510(k) Data Aggregation
K Number
K201302Device Name
LiveOne
Manufacturer
Date Cleared
2022-05-04
(719 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
LiveMetric (Medical) S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure and hemodynamic monitor.
The LiveOne is intended to be used on subjects ≥ 27 years old and who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing the patient's cardiac health via blood pressure readings in clinic setting by health care professional. LiveOne is intended only for measurement and display; it makes no diagnosis.
Device Description
The LiveOne is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, and pulse rate and a pressure waveform. The device allows the healthcare provider to monitor blood pressure (based on visual waveform) in a clinical setting.
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