FDA 510(k)

Medke Oximetry Finger Sensor

K-Number: K152390 · 2016-08-18

ApplicantShenzhen Medke Technology Co., Ltd.

Decision Date2016-08-18

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Medke Oximetry Finger Sensor is a medical device manufactured by Shenzhen Medke Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-08-18 under approval number K152390. 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 Medke Oximetry Finger Sensor?

Medke Oximetry Finger Sensor is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by Shenzhen Medke Technology Co., Ltd.. The 510(k) number is K152390.

When was Medke Oximetry Finger Sensor approved by the FDA?

Medke Oximetry Finger Sensor received FDA 510(k) clearance on 2016-08-18, under approval number K152390.

What company makes Medke Oximetry Finger Sensor?

Medke Oximetry Finger Sensor is manufactured by Shenzhen Medke Technology Co., Ltd..

What is the FDA product code for Medke Oximetry Finger Sensor?

The FDA product code for Medke Oximetry Finger Sensor is DQA.

Related Clinical Trials

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Other Devices by Shenzhen Medke Technology Co., Ltd.

K242623Disposable Blood Pressure cuff; Reusable Blood Pressure cuff K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology 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.