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FDA 510(k)

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)

K-Number: K213984 · 2022-12-16

ApplicantShenzhen Zhengkang Technology Co., Ltd.
Decision Date2022-12-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) is a medical device manufactured by Shenzhen Zhengkang Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under approval number K213984. 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 Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Shenzhen Zhengkang Technology Co., Ltd.. The 510(k) number is K213984.

When was Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) approved by the FDA?

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) received FDA 510(k) clearance on 2022-12-16, under approval number K213984.

What company makes Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) is manufactured by Shenzhen Zhengkang Technology Co., Ltd..

What is the FDA product code for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

The FDA product code for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) is DQA.

Other Devices by Shenzhen Zhengkang Technology Co., Ltd.

K191894Upper Arm Blood Pressure Monitor K203707Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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