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510(k) Data Aggregation
K Number
K210086Device Name
Vitals360 Multi-Vitals Mobile Monitor
Manufacturer
VoCare, Inc.
Date Cleared
2021-05-20
(127 days)
Product Code
MWI, DQA, DSH, DXN, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
VoCare, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
Device Description
The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.
The Vitals360® capabilities include storing, displaying measuring data.
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