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FDA 510(k)

Finger Pulse Oximeter

K-Number: K163135 · 2017-09-19

ApplicantShenzhen Fitfaith Technology Co.,Ltd
Decision Date2017-09-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Finger Pulse Oximeter is a medical device manufactured by Shenzhen Fitfaith Technology Co.,Ltd. It received FDA 510(k) clearance on 2017-09-19 under approval number K163135. 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 Finger Pulse Oximeter?

Finger Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2017-09-19. It is manufactured by Shenzhen Fitfaith Technology Co.,Ltd. The 510(k) number is K163135.

When was Finger Pulse Oximeter approved by the FDA?

Finger Pulse Oximeter received FDA 510(k) clearance on 2017-09-19, under approval number K163135.

What company makes Finger Pulse Oximeter?

Finger Pulse Oximeter is manufactured by Shenzhen Fitfaith Technology Co.,Ltd.

What is the FDA product code for Finger Pulse Oximeter?

The FDA product code for Finger 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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