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FDA 510(k)

Disposable SpO2 Sensor

K-Number: K192608 · 2020-01-24

ApplicantShenzhen Sino-K Medical Technology Co.,Ltd
Decision Date2020-01-24
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable SpO2 Sensor is a medical device manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-01-24 under approval number K192608. 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 Disposable SpO2 Sensor?

Disposable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K192608.

When was Disposable SpO2 Sensor approved by the FDA?

Disposable SpO2 Sensor received FDA 510(k) clearance on 2020-01-24, under approval number K192608.

What company makes Disposable SpO2 Sensor?

Disposable SpO2 Sensor is manufactured by Shenzhen Sino-K Medical Technology Co.,Ltd.

What is the FDA product code for Disposable SpO2 Sensor?

The FDA product code for Disposable SpO2 Sensor 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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