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510(k) Data Aggregation
K Number
K213431Device Name
Handheld Pulse Oximeter
Manufacturer
Date Cleared
2023-02-26
(493 days)
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Witleaf Medical Electronics Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Handheld Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.
Device Description
The Handheld Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Handheld Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Handheld Pulse Oximeter is powered by 3 AA batteries. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The Handheld Pulse Oximeter is compatible with S0010B-S sensor. The device is a spot-check Handheld Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
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K Number
K213430Device Name
Fingertip Pulse Oximeter
Manufacturer
Date Cleared
2022-12-30
(435 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Witleaf Medical Electronics Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
Device Description
The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
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