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FDA 510(k)

Reusable & Disposable SpO2 Sensors

K-Number: K173368 · 2018-08-31

ApplicantShenzhen Coreray Technology, Ltd.
Decision Date2018-08-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reusable & Disposable SpO2 Sensors is a medical device manufactured by Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2018-08-31 under approval number K173368. 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 Reusable & Disposable SpO2 Sensors?

Reusable & Disposable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by Shenzhen Coreray Technology, Ltd.. The 510(k) number is K173368.

When was Reusable & Disposable SpO2 Sensors approved by the FDA?

Reusable & Disposable SpO2 Sensors received FDA 510(k) clearance on 2018-08-31, under approval number K173368.

What company makes Reusable & Disposable SpO2 Sensors?

Reusable & Disposable SpO2 Sensors is manufactured by Shenzhen Coreray Technology, Ltd..

What is the FDA product code for Reusable & Disposable SpO2 Sensors?

The FDA product code for Reusable & Disposable SpO2 Sensors is 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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