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FDA 510(k)

Infared Thermometer

K-Number: K191251 · 2019-10-15

ApplicantShenzhen Calibeur Industries Co., Ltd.
Decision Date2019-10-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infared Thermometer is a medical device manufactured by Shenzhen Calibeur Industries Co., Ltd.. It received FDA 510(k) clearance on 2019-10-15 under approval number K191251. 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 Infared Thermometer?

Infared Thermometer is a medical device that received FDA 510(k) clearance on 2019-10-15. It is manufactured by Shenzhen Calibeur Industries Co., Ltd.. The 510(k) number is K191251.

When was Infared Thermometer approved by the FDA?

Infared Thermometer received FDA 510(k) clearance on 2019-10-15, under approval number K191251.

What company makes Infared Thermometer?

Infared Thermometer is manufactured by Shenzhen Calibeur Industries Co., Ltd..

What is the FDA product code for Infared Thermometer?

The FDA product code for Infared Thermometer is 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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