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510(k) Data Aggregation
K Number
K201887Device Name
VS Newborn Heart Rate Monitor
Manufacturer
Date Cleared
2021-07-23
(380 days)
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SurePulse Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Device Description
The VS Newborn Heart Rate Monitor is a non-invasive device intended to continuously monitor heart rate (HR) in neonates immediately after delivery and in newborn intensive care units (NICU). The VS Newborn Heart Rate Monitor measures HR using reflectance photoplethysmography (PPG). The sensor is integrated into a single-use soft cap placed on the head of the newborn such that the sensor contacts the forehead of the newborn. The PPG signal and HR are displayed on the monitor. The VS Newborn Heart Rate Monitor is designed for use in hospitals.
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