Fingertip Pulse Oximeter, Model MD300CA ND300CA
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092652 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A fingertip pulse oximeter is a non-invasive device used to measure oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. This device is intended for spot-check use in adult and pediatric patients.
It is designed for use in home and hospital settings, including clinical environments such as internal medicine, surgery, anesthesia, and intensive care. The device is supplied as a portable unit and has received FDA 510(k) clearance under K092652, classified as a Class II medical device with product code DQA.
Frequently asked questions
What is the Fingertip Pulse Oximeter Model MD300CA ND300CA used for?
It is used to non-invasively measure oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for spot-check monitoring in adult and pediatric patients, suitable for home and hospital settings including internal medicine, surgery, anesthesia, and intensive care.
How is the Fingertip Pulse Oximeter Model MD300CA ND300CA supplied and is it reusable?
The device is supplied as a portable unit designed for repeated use; it is not single-use and can be used multiple times for spot-check measurements in clinical or home environments.
What regulatory pathway was used for the Fingertip Pulse Oximeter Model MD300CA ND300CA?
The device received FDA 510(k) clearance under submission K092652, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device with product code DQA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fingertip Pulse Oximeter, Model Md300ca Nd300ca, Fingertip Pulse Oximeter, Model Md300ca Nd300ca, K092652 - FINGERTIP PULSE OXIMETER | FDA 510 (k), PDF K092652 - Fingertip Pulse Oximeter, Model Md300ca Nd300ca
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092652 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technololgy Co., Ltd.
Sources (1)
- FDA 510(k) K092652 24 fields · synced Sep 27, 2026