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FDA 510(k)

Caremed Reusable & Disposable SPO2 Sensors

K-Number: K153184 · 2017-01-04

ApplicantShenzhen Caremed Medical Technology Co., Ltd.
Decision Date2017-01-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Caremed Reusable & Disposable SPO2 Sensors is a medical device manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under approval number K153184. 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 Caremed Reusable & Disposable SPO2 Sensors?

Caremed Reusable & Disposable SPO2 Sensors is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K153184.

When was Caremed Reusable & Disposable SPO2 Sensors approved by the FDA?

Caremed Reusable & Disposable SPO2 Sensors received FDA 510(k) clearance on 2017-01-04, under approval number K153184.

What company makes Caremed Reusable & Disposable SPO2 Sensors?

Caremed Reusable & Disposable SPO2 Sensors is manufactured by Shenzhen Caremed Medical Technology Co., Ltd..

What is the FDA product code for Caremed Reusable & Disposable SPO2 Sensors?

The FDA product code for Caremed Reusable & Disposable SPO2 Sensors is DQA.

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

K153188Caremed patient cable and leadwires K182755Disposable Temperature Probe K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff K191279Disposable SpO2 Sensor 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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