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Fingertip Pulse Oximeter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142888

by Beijing Choice Electronic Technololgy Co., Ltd.

Identifiers

510(k) Number
K142888 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 (SpO2) and pulse rate in arterial blood. It operates by emitting light through the fingertip and detecting changes in light absorption to determine SpO2 levels and heart rate.

This device is intended for use in homecare and primary care settings. It is supplied as a reusable, non-sterile device and has received FDA 510(k) clearance under product code DQA, with K-number K142888. The device is manufactured by Beijing Choice Electronic Technology Co., Ltd. and is authorized for marketing in the United States.

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, Fingertip Pulse Oximeter MD300C29 - ChoiceMMed, Fingertip pulse oximeter - MD300CN130 - 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 Technololgy Co., Ltd.

Sources (1)

  • FDA 510(k) K142888 24 fields · synced Sep 22, 2026