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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) 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. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. The 510(k) number is K213984.

When did Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) receive FDA 510(k) clearance?

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

Who is the listed applicant for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

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

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 records listing Shenzhen Zhengkang 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.

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

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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