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FDA 510(k)

Pulse Oximeter

K-Number: K203854 · 2021-04-23

ApplicantShenzhen Hexin Zondan Medical Equipment Co., Ltd.
Decision Date2021-04-23
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter is a medical device manufactured by Shenzhen Hexin Zondan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-04-23 under approval number K203854. 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 Pulse Oximeter?

Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Shenzhen Hexin Zondan Medical Equipment Co., Ltd.. The 510(k) number is K203854.

When was Pulse Oximeter approved by the FDA?

Pulse Oximeter received FDA 510(k) clearance on 2021-04-23, under approval number K203854.

What company makes Pulse Oximeter?

Pulse Oximeter is manufactured by Shenzhen Hexin Zondan Medical Equipment Co., Ltd..

What is the FDA product code for Pulse Oximeter?

The FDA product code for Pulse Oximeter is DQA.

Related Clinical Trials

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Related Devices (Code: DQA)

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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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