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510(k) Data Aggregation
K Number
K190893Device Name
Non-invasive Hemodynamic Blood Pressure Monitor
Manufacturer
Date Cleared
2019-08-07
(124 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Vita-Course Technologies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
Device Description
Discovery 1 is a portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery. It contains a pulse wave probe incorporating two LEDs, which can collect the pulse wave to the device.
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