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FDA 510(k)

Disposable SpO2 Sensor

K-Number: K191279 · 2019-12-06

ApplicantShenzhen Caremed Medical Technology Co., Ltd.
Decision Date2019-12-06
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable SpO2 Sensor is a medical device manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-06 under approval number K191279. 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 2019-12-06. It is manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K191279.

When was Disposable SpO2 Sensor approved by the FDA?

Disposable SpO2 Sensor received FDA 510(k) clearance on 2019-12-06, under approval number K191279.

What company makes Disposable SpO2 Sensor?

Disposable SpO2 Sensor is manufactured by Shenzhen Caremed Medical Technology Co., Ltd..

What is the FDA product code for Disposable SpO2 Sensor?

The FDA product code for Disposable SpO2 Sensor is DQA.

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Other Devices by Shenzhen Caremed Medical Technology Co., Ltd.

K153188Caremed patient cable and leadwires K153184Caremed Reusable & Disposable SPO2 Sensors K182755Disposable Temperature Probe K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff K182751Reusable Temperature Probe

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.

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