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FDA 510(k)

Disposable SpO2 Sensor

K-Number: K192608 · 2020-01-24

ApplicantShenzhen Sino-K Medical Technology Co.,Ltd
Decision Date2020-01-24
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K192608. 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 Disposable SpO2 Sensor?

Disposable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K192608.

When did Disposable SpO2 Sensor receive FDA 510(k) clearance?

Disposable SpO2 Sensor received FDA 510(k) clearance on 2020-01-24, under 510(k) number K192608.

Who is the listed applicant for Disposable SpO2 Sensor?

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

What is the FDA product code for Disposable SpO2 Sensor?

The FDA product code for Disposable SpO2 Sensor is DQA.

Other records listing Shenzhen Sino-K Medical 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.

K231961NIBPCuffK223807Reusable Temperature Probe, Disposable Temperature Probe

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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