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Fingertip Pulse Oximeter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123871

by Beijing Choice Electronic Technololgy Co., Ltd.

Identifiers

510(k) Number
K123871 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 MD300C208 is a non-invasive medical device classified as a pulse oximeter, designed to measure oxygen saturation (SpO₂) in arterial blood and pulse rate. It operates by emitting light through a fingertip sensor to detect hemoglobin oxygenation levels, providing real-time monitoring of vital signs. This device is intended for clinical and home-use settings to assess patient oxygenation status. Its compact design allows for portable and convenient use in various healthcare environments.

The Fingertip Pulse Oximeter MD300C208 is supplied as a single-use or reusable device, depending on manufacturer guidelines, and is intended for use in non-MRI environments. It is regulated under FDA 510(k) clearance (K123871) as substantially equivalent to a predicate device, with a classification under product code DQA. Proper storage requires protection from extreme temperatures and moisture, adhering to manufacturer instructions for optimal performance and longevity.

Frequently asked questions

What is the Fingertip Pulse Oximeter MD300C208 used for?

The MD300C208 Fingertip Pulse Oximeter is designed to measure oxygen saturation (SpO₂) in arterial blood and pulse rate non-invasively. It uses a fingertip sensor that emits light to detect hemoglobin oxygenation levels, providing real-time monitoring of vital signs. This makes it suitable for assessing patient oxygenation status in both clinical and home settings.

Is the MD300C208 Fingertip Pulse Oximeter single-use or reusable?

The MD300C208 Fingertip Pulse Oximeter can be used either as a single-use or reusable device, depending on the manufacturer’s guidelines. For optimal performance and hygiene, follow the manufacturer’s instructions regarding usage and reprocessing if intended for reuse.

What storage conditions are required for the MD300C208 Fingertip Pulse Oximeter?

To maintain performance and longevity, the device must be stored in a protected environment away from extreme temperatures and moisture. Adhering strictly to the manufacturer’s storage instructions ensures reliable operation and extends the device’s lifespan.

Can the MD300C208 Fingertip Pulse Oximeter be used in MRI environments?

No, the MD300C208 Fingertip Pulse Oximeter is not intended for use in MRI environments. Its design and materials are not compatible with magnetic resonance imaging settings, which require specialized, non-ferromagnetic devices.

What regulatory clearance does the MD300C208 Fingertip Pulse Oximeter hold?

The MD300C208 Fingertip Pulse Oximeter holds FDA 510(k) clearance under the reference number K123871. This clearance classifies it as substantially equivalent to a predicate device, with a product code of DQA, and was reviewed by the FDA’s Cardiovascular Advisory Committee.

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 Co., Ltd., ChoiceMMed, Handheld Pulse Oximeter MD300MNR - ChoiceMMed, Beijing Choice Electronic Technology Co., Ltd., Beijing Choice Electronic Technology Fingertip Pulse Oximeter Operator ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beijing Choice Electronic Technololgy Co., Ltd.

Sources (1)

  • FDA 510(k) K123871 24 fields · synced Oct 1, 2026