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FDA 510(k)

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304

K-Number: K211050 · 2022-11-28

ApplicantJkh Health Co., Ltd.
Decision Date2022-11-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2022-11-28 under approval number K211050. 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 Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304?

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 is a medical device that received FDA 510(k) clearance on 2022-11-28. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K211050.

When was Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 approved by the FDA?

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 received FDA 510(k) clearance on 2022-11-28, under approval number K211050.

What company makes Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304?

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 is manufactured by Jkh Health Co., Ltd..

What is the FDA product code for Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304?

The FDA product code for Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 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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