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FDA 510(k)

Infrared ear and forehead thermometer, model YI-100

K-Number: K201843 · 2020-10-23

Decision Date2020-10-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared ear and forehead thermometer, model YI-100 is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K201843. 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 ear and forehead thermometer, model YI-100?

Infrared ear and forehead thermometer, model YI-100 is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. The 510(k) number is K201843.

When did Infrared ear and forehead thermometer, model YI-100 receive FDA 510(k) clearance?

Infrared ear and forehead thermometer, model YI-100 received FDA 510(k) clearance on 2020-10-23, under 510(k) number K201843.

Who is the listed applicant for Infrared ear and forehead thermometer, model YI-100?

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

What is the FDA product code for Infrared ear and forehead thermometer, model YI-100?

The FDA product code for Infrared ear and forehead thermometer, model YI-100 is FLL.

Other records listing Wenzhou Yosun Medical 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.

Related Devices (Code: FLL)

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.

Official Source

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