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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fitfaith Technology Co.,Ltd. It received FDA 510(k) clearance on 2017-09-19 under 510(k) 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. The listed applicant is Shenzhen Fitfaith Technology Co.,Ltd. The 510(k) number is K163135.

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

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

Who is the listed applicant for Finger Pulse Oximeter?

The FDA 510(k) record lists Shenzhen Fitfaith Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finger Pulse Oximeter?

The FDA product code for Finger Pulse Oximeter 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.

NCT04796285A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk MonitorACTIVE_NOT_RECRUITINGNCT05690633Feasibility of Obtaining Pulse Oximetry Readings From the OropharynxCOMPLETEDNCT05977686Hemoglobin Testing in Pregnant PatientsRECRUITING

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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