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510(k) Data Aggregation
K Number
K190090Device Name
DynoSense Vital Sign Measuring System
Manufacturer
Date Cleared
2019-08-02
(197 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
DynoSense Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG), heart rate (HR), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features.
This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition.
This system makes no specific diagnosis. The device is for single patient use.
Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device.
Device Description
The DynoSense Vital Sign Measuring System is a battery-powered, handheld, personalized single patient use vital sign measuring apparatus. The user must hold the Device with their left hand. Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements are based on transmittance of light through the index finger. Respiration rate (RR) measurements are based on pressure change at the aperture opening during breathing. Oral temperature (TEMP) is measured via sublingual and lingual contact with the thermometer tip. ECG and heart rate (HR) measurements are obtained via completing an electrical path across the left side of the chest. Vital sign data are communicated to a Bluetooth-capable mobile platform for forwarding to the cloud application for processing and storage.
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