Fingertip Pulse Oximeter MD300C
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070371 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)
The Fingertip Pulse Oximeter MD300C is a non-invasive medical device classified as a pulse oximeter, designed to measure arterial hemoglobin oxygen saturation (SpO₂) and pulse rate. It operates by emitting dual-wavelength light (660 nm red and 940 nm infrared) through a fingertip sensor, detecting variations in light absorption to estimate oxygenation levels. This device provides real-time, continuous monitoring of vital signs, aiding in the assessment of respiratory and circulatory function. Its compact design enables portable use in clinical and home settings.
The MD300C is supplied as a single-use or reusable device, depending on the sensor attachment, and requires no special sterility conditions beyond standard clinical hygiene practices. It is intended for use in hospital wards, emergency rooms, and outpatient clinics, where quick and accurate SpO₂ readings are critical. The device has received FDA 510(k) clearance under the traditional pathway, with a classification under product code DQA. No specific MRI safety information is provided, and storage should follow manufacturer guidelines to maintain accuracy and functionality.
Frequently asked questions
What is the Fingertip Pulse Oximeter MD300C used for?
The MD300C is designed to non-invasively measure arterial hemoglobin oxygen saturation (SpO₂) and pulse rate. It uses dual-wavelength light (red and infrared) to detect variations in light absorption through a fingertip sensor, providing real-time data on oxygenation and circulatory function. This is particularly useful in hospital wards, emergency rooms, and outpatient clinics where quick and accurate vital sign assessment is critical.
How is the MD300C supplied, and what are the sterility requirements?
The MD300C can be supplied with either single-use or reusable sensor attachments, depending on the configuration. For reusable sensors, standard clinical hygiene practices—such as cleaning and disinfection between uses—are required to maintain safety and accuracy. No special sterility conditions beyond routine clinical protocols are specified.
Can the MD300C be used in portable settings, and how does its design support this?
Yes, the MD300C is designed with a compact form factor, making it suitable for portable use in both clinical and home environments. Its lightweight and handheld nature allows for easy transport and on-the-go monitoring of SpO₂ and pulse rate, ideal for scenarios where mobility is required.
What are the key specifications of the MD300C’s light technology?
The device employs dual-wavelength light technology, emitting 660 nm (red) and 940 nm (infrared) light through the fingertip sensor. These wavelengths are chosen to penetrate tissue and detect differences in light absorption caused by oxygenated and deoxygenated hemoglobin, enabling accurate SpO₂ measurement.
Are there any special storage instructions for the MD300C?
While the device data does not specify exact storage conditions, it advises following the manufacturer’s guidelines to preserve accuracy and functionality. Generally, this would include protecting the device from extreme temperatures, moisture, and physical damage, as well as ensuring sensors are stored cleanly if reusable.
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: Beijing Choice Electronic Technology MD300C1C Operator's Manual, Beijing Choice Electronic Technology Fingertip Pulse Oximeter Operator ..., Beijing Choice Electronic Technology Co., Ltd., FINGERTIP PULSE OXIMETER MD300C (K070371) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070371 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Choice Electronic Technololgy Co., Ltd.
Sources (1)
- FDA 510(k) K070371 24 fields · synced Oct 1, 2026