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510(k) Data Aggregation
K Number
K230277Device Name
Pulse Oximeter(Model OHT60,OXH78)
Manufacturer
Date Cleared
2024-01-04
(337 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Cofoe Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion.
Device Description
The pulse oximeter, Model OHT60 and OXH78, consists of probe, electronic circuits, and display and plastic enclosures, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a professional healthcare facility or home conditions when physician follow-up and operated by a physician. This medical device can be reused. Not for continuously monitoring.
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The measurement principle of Pulse oximeter is based on the absorption spectrum characteristics of hemoglobin and oxyhemoglobin in red and infrared regions, and the empirical formula of data is established by using ' Lambert Beer ' law. The working principle of the instrument adopts photoelectric blood oxygen detection technology combined with volume pulse recording technology, The specific process is as follows: Firstly, the infrared light emitting at 660 nm and the near-infrared light emitting at 905 are used to irradiate the finger and the measurement data are obtained by the infrared receiver tube. Secondly, the obtained measurement data were calculated and processed by electronic circuits and microprocessors to obtain the blood oxygen saturation and pulse rate, and the calculation results were displayed on the screen.
The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA alkaline batteries.
The Model OHT60 and OXH78 have the same critical components and its materials and means of power supply, PCB layout and Software are little different.
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