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510(k) Data Aggregation
K Number
K143216Device Name
Assurance Alar / Nasal SpO2 Sensor
Manufacturer
Xhale, Inc.
Date Cleared
2015-03-17
(127 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Xhale, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Assurance™ Nasal / Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (weighing > 30kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.
Device Description
The Alar / Nasal SpO2 Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Alar / Nasal SpO2 Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor SpO2 technology.
The sensor utilizes red and IR LED light sources of 660 nm and 880 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.
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