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FDA 510(k)

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603

K-Number: K203707 · 2021-03-12

ApplicantShenzhen Zhengkang Technology Co., Ltd.
Decision Date2021-03-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is a medical device manufactured by Shenzhen Zhengkang Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under approval number K203707. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by Shenzhen Zhengkang Technology Co., Ltd.. The 510(k) number is K203707.

When was Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 approved by the FDA?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 received FDA 510(k) clearance on 2021-03-12, under approval number K203707.

What company makes Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is manufactured by Shenzhen Zhengkang Technology Co., Ltd..

What is the FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

The FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is FLL.

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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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