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FDA 510(k)

Reusable SpO2 Sensors, Disposable SpO2 Sensors

K-Number: K172981 · 2018-06-08

ApplicantAPK Technology Co., Ltd.
Decision Date2018-06-08
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reusable SpO2 Sensors, Disposable SpO2 Sensors is a medical device manufactured by APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-06-08 under approval number K172981. 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 SpO2 Sensors, Disposable SpO2 Sensors?

Reusable SpO2 Sensors, Disposable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2018-06-08. It is manufactured by APK Technology Co., Ltd.. The 510(k) number is K172981.

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

Reusable SpO2 Sensors, Disposable SpO2 Sensors received FDA 510(k) clearance on 2018-06-08, under approval number K172981.

What company makes Reusable SpO2 Sensors, Disposable SpO2 Sensors?

Reusable SpO2 Sensors, Disposable SpO2 Sensors is manufactured by APK Technology Co., Ltd..

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

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

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Official Source

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

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