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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 the device name listed in this FDA 510(k) record. The listed applicant is Amemo, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) 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. The listed applicant is Amemo, Inc.. The 510(k) number is K153021.

When did Fingertip Pulse Oximeter A310 receive FDA 510(k) clearance?

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

Who is the listed applicant for Fingertip Pulse Oximeter A310?

The FDA 510(k) record lists Amemo, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07686341PRecision Integrated Saturation MonitorRECRUITING

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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