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FDA 510(k)

Reusable & Disposable SpO2 Sensors

K-Number: K173368 · 2018-08-31

Decision Date2018-08-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reusable & Disposable SpO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) 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. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K173368.

When did Reusable & Disposable SpO2 Sensors receive FDA 510(k) clearance?

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

Who is the listed applicant for Reusable & Disposable SpO2 Sensors?

The FDA 510(k) record lists Shenzhen Coreray Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Reusable & Disposable SpO2 Sensors is DQA.

Other records listing Shenzhen Coreray Technology, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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