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FDA 510(k)

Wrist Pulse Oximeter

K-Number: K230587 · 2023-11-30

ApplicantBeijing Choice Electronic Technology Co., Ltd.
Decision Date2023-11-30
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Pulse Oximeter is a medical device manufactured by Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-30 under approval number K230587. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist Pulse Oximeter?

Wrist Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K230587.

When was Wrist Pulse Oximeter approved by the FDA?

Wrist Pulse Oximeter received FDA 510(k) clearance on 2023-11-30, under approval number K230587.

What company makes Wrist Pulse Oximeter?

Wrist Pulse Oximeter is manufactured by Beijing Choice Electronic Technology Co., Ltd..

What is the FDA product code for Wrist Pulse Oximeter?

The FDA product code for Wrist Pulse Oximeter is DQA.

Related Clinical Trials

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Other Devices by Beijing Choice Electronic Technology Co., Ltd.

K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51 K161560Fingertip Pulse Oximeter MD300CN310 K152563Pulse Oximeter (MD300M/MD300K2) K162089Blood Pressure Monitor K181503Fingertip Pulse Oximeter K172366Wrist Pulse Oximeter

View all 14 devices →

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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