FDA 510(k)

Infrared forehead thermometer LD-FT-100B

K-Number: K211629 · 2021-12-08

Decision Date2021-12-08

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Infrared forehead thermometer LD-FT-100B is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K211629. 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 forehead thermometer LD-FT-100B?

Infrared forehead thermometer LD-FT-100B is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K211629.

When did Infrared forehead thermometer LD-FT-100B receive FDA 510(k) clearance?

Infrared forehead thermometer LD-FT-100B received FDA 510(k) clearance on 2021-12-08, under 510(k) number K211629.

Who is the listed applicant for Infrared forehead thermometer LD-FT-100B?

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

What is the FDA product code for Infrared forehead thermometer LD-FT-100B?

The FDA product code for Infrared forehead thermometer LD-FT-100B is FLL.

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Related Devices (Code: 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.