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FDA 510(k)

INFRARED BODY THERMOMETER (Model: YK-001)

K-Number: K210118 · 2021-09-15

ApplicantLongnan Renzhong Medical Equipment Co., Ltd.
Decision Date2021-09-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED BODY THERMOMETER (Model: YK-001) is a medical device manufactured by Longnan Renzhong Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-15 under approval number K210118. 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 BODY THERMOMETER (Model: YK-001)?

INFRARED BODY THERMOMETER (Model: YK-001) is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Longnan Renzhong Medical Equipment Co., Ltd.. The 510(k) number is K210118.

When was INFRARED BODY THERMOMETER (Model: YK-001) approved by the FDA?

INFRARED BODY THERMOMETER (Model: YK-001) received FDA 510(k) clearance on 2021-09-15, under approval number K210118.

What company makes INFRARED BODY THERMOMETER (Model: YK-001)?

INFRARED BODY THERMOMETER (Model: YK-001) is manufactured by Longnan Renzhong Medical Equipment Co., Ltd..

What is the FDA product code for INFRARED BODY THERMOMETER (Model: YK-001)?

The FDA product code for INFRARED BODY THERMOMETER (Model: YK-001) 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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