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FDA 510(k)

Non-contact Forehead Thermometer

K-Number: K161735 · 2016-11-17

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2016-11-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-contact Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K161735. 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?

Non-contact Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K161735.

When did Non-contact Forehead Thermometer receive FDA 510(k) clearance?

Non-contact Forehead Thermometer received FDA 510(k) clearance on 2016-11-17, under 510(k) number K161735.

Who is the listed applicant for Non-contact Forehead Thermometer?

The FDA 510(k) record lists Shenzhen Dongdixin Technology 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?

The FDA product code for Non-contact Forehead Thermometer 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.

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