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FDA 510(k)

Fingertip Pulse Oximeter

K-Number: K152091 · 2016-08-18

ApplicantJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
Decision Date2016-08-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fingertip Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K152091. 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?

Fingertip Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.. The 510(k) number is K152091.

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

Fingertip Pulse Oximeter received FDA 510(k) clearance on 2016-08-18, under 510(k) number K152091.

Who is the listed applicant for Fingertip Pulse Oximeter?

The FDA 510(k) record lists Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fingertip Pulse Oximeter?

The FDA product code for Fingertip 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.

NCT07686341PRecision Integrated Saturation MonitorRECRUITING

Other records listing Jiangsu Konsung Bio-Medical Science & Technology 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.

K152089Wrist Pulse Oximeter

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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