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FDA 510(k)

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

K-Number: K203747 · 2021-01-25

Decision Date2021-01-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-25 under 510(k) number K203747. 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 Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203747.

When did Non-Contact Forehead Thermometer (Models UT306H & UT308H) receive FDA 510(k) clearance?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) received FDA 510(k) clearance on 2021-01-25, under 510(k) number K203747.

Who is the listed applicant for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

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

What is the FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

The FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H) is FLL.

Other records listing Uni-Trend Technology (China) 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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