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FDA 510(k)

THERMOCLICK

K-Number: K222057 · 2023-12-05

Decision Date2023-12-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOCLICK is the device name listed in this FDA 510(k) record. The listed applicant is T&R BIOFAB CO., Ltd.. It received FDA 510(k) clearance on 2023-12-05 under 510(k) 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. The listed applicant is T&R BIOFAB CO., Ltd.. The 510(k) number is K222057.

When did THERMOCLICK receive FDA 510(k) clearance?

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

Who is the listed applicant for THERMOCLICK?

The FDA 510(k) record lists T&R BIOFAB CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOCLICK?

The FDA product code for THERMOCLICK is FLL.

Other records listing T&R BIOFAB 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.