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510(k) Data Aggregation
K Number
K232495Device Name
Sempulse Halo Vital Signs Monitor
Manufacturer
Date Cleared
2024-05-16
(273 days)
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Sempulse Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Halo vital signs monitor is a prescription device intended to be used as an adult patient monitor. It is indicated as a single- or multi-parameter vital signs monitor for SpO2 - pulse oximetry, pulse rate, respiratory rate, core body temperature, and skin temperature for spot-check measurements and continuous monitoring from the back of the cavum concha and the neck.
The Halo monitor may be used in hospitals, healthcare facilities, emergency medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field. The monitor is intended to be used in trauma scenarios, triage, motion, low perfusion, general monitoring, and telemedicine settings. It is reusable, transportable, and for use in all types of ambulances.
The Halo monitor uses wired or wireless communications to transmit vital signs data to a handheld or personal computer. The monitor is intended to be used by trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are und guidance of a medical professional or doctor. Alarms can be set with user-defined thresholds.
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