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Fingertip Pulse Oximeter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181503

by Beijing Choice Electronic Technology Co., Ltd.

Identifiers

510(k) Number
K181503 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 via photoplethysmography. It adheres to the definition of a fingertip pulse oximeter, a category of devices used for continuous or intermittent monitoring of oxygenation levels in patients.

This device is intended for single-use or reusable applications in clinical, home, or pre-hospital settings, depending on manufacturer guidelines. Supplied sterile or non-sterile as specified by the user facility, it operates without MRI compatibility restrictions. The device is authorised under FDA 510(k) clearance (K181503) and is distributed by Beijing Choice Electronic Technology Co., Ltd. Storage conditions and usage instructions must follow the manufacturer’s provided guidelines to ensure accuracy and reliability.

Frequently asked questions

What clinical settings can this pulse oximeter be used in, and how is it typically supplied?

The Fingertip Pulse Oximeter MD300C208 is designed for use in clinical, home, or pre-hospital settings. It can be used for either single-use or reusable applications, depending on the facility’s guidelines. Sterility (sterile or non-sterile) is determined by the user’s facility based on their specific protocols, as the device itself does not specify a default sterility state.

Can this device be used in an MRI environment, and what are its key measurement capabilities?

No, the Fingertip Pulse Oximeter MD300C208 is not MRI-compatible, so it should not be used in magnetic resonance imaging environments. It measures oxygen saturation (SpO₂) in arterial blood and pulse rate using photoplethysmography, making it suitable for continuous or intermittent monitoring of oxygenation levels.

How is the regulatory status of this device determined, and who is responsible for compliance?

The device holds FDA 510(k) clearance under the reference number K181503, classified as substantially equivalent to a predicate device. Compliance with regulatory requirements, including storage and usage guidelines, falls under the responsibility of the manufacturer, Beijing Choice Electronic Technology Co., Ltd., based in Beijing, China.

What should I consider when storing this device to maintain its accuracy and reliability?

Storage conditions must follow the manufacturer’s guidelines to ensure the device’s accuracy and reliability. While specific storage instructions are not detailed in the data, adherence to general environmental standards (e.g., avoiding extreme temperatures or humidity) is implied, as outlined in the manufacturer’s provided instructions.

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 Manufacturer | Choicemmed, ChoiceMMed, Handheld Pulse Oximeter MD300MNR - ChoiceMMed, Fingertip pulse oximeter - MD300C55 - Beijing Choice Electronic ..., 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 Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K181503 24 fields · synced Sep 19, 2026