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FDA 510(k)

YUWELL Finger Pulse Oximeter

K-Number: K212385 · 2022-08-16

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2022-08-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

YUWELL Finger Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K212385. 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 YUWELL Finger Pulse Oximeter?

YUWELL Finger Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K212385.

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

YUWELL Finger Pulse Oximeter received FDA 510(k) clearance on 2022-08-16, under 510(k) number K212385.

Who is the listed applicant for YUWELL Finger Pulse Oximeter?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YUWELL Finger Pulse Oximeter?

The FDA product code for YUWELL 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

Other records listing Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as applicant

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.

K261571Manual Wheelchair (H008, PCK7)K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

View all 13 devices →

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

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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