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FDA 510(k)

Fingertip Pulse Oximeter A310

K-Number: K153021 · 2016-11-22

ApplicantAmemo, Inc.
Decision Date2016-11-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fingertip Pulse Oximeter A310 is a medical device manufactured by Amemo, Inc.. It received FDA 510(k) clearance on 2016-11-22 under approval number K153021. 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 Fingertip Pulse Oximeter A310?

Fingertip Pulse Oximeter A310 is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Amemo, Inc.. The 510(k) number is K153021.

When was Fingertip Pulse Oximeter A310 approved by the FDA?

Fingertip Pulse Oximeter A310 received FDA 510(k) clearance on 2016-11-22, under approval number K153021.

What company makes Fingertip Pulse Oximeter A310?

Fingertip Pulse Oximeter A310 is manufactured by Amemo, Inc..

What is the FDA product code for Fingertip Pulse Oximeter A310?

The FDA product code for Fingertip Pulse Oximeter A310 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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