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FDA 510(k)

Digital Thermometer, Model T28, T28L

K-Number: K232678 · 2024-01-31

Decision Date2024-01-31
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital Thermometer, Model T28, T28L is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under 510(k) number K232678. 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 Digital Thermometer, Model T28, T28L?

Digital Thermometer, Model T28, T28L is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K232678.

When did Digital Thermometer, Model T28, T28L receive FDA 510(k) clearance?

Digital Thermometer, Model T28, T28L received FDA 510(k) clearance on 2024-01-31, under 510(k) number K232678.

Who is the listed applicant for Digital Thermometer, Model T28, T28L?

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

What is the FDA product code for Digital Thermometer, Model T28, T28L?

The FDA product code for Digital Thermometer, Model T28, T28L is FLL.

Other records listing Guangdong Genial 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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