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FDA 510(k)

THERMOCLICK

K-Number: K222057 · 2023-12-05

ApplicantT&R BIOFAB CO., Ltd.
Decision Date2023-12-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOCLICK is a medical device manufactured by T&R BIOFAB CO., Ltd.. It received FDA 510(k) clearance on 2023-12-05 under approval number K222057. 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 THERMOCLICK?

THERMOCLICK is a medical device that received FDA 510(k) clearance on 2023-12-05. It is manufactured by T&R BIOFAB CO., Ltd.. The 510(k) number is K222057.

When was THERMOCLICK approved by the FDA?

THERMOCLICK received FDA 510(k) clearance on 2023-12-05, under approval number K222057.

What company makes THERMOCLICK?

THERMOCLICK is manufactured by T&R BIOFAB CO., Ltd..

What is the FDA product code for THERMOCLICK?

The FDA product code for THERMOCLICK 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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