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FDA 510(k)

Bencox THR System

K-Number: K211866 · 2021-07-14

ApplicantCorentec Co., Ltd.
Decision Date2021-07-14
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bencox THR System is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K211866. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bencox THR System?

Bencox THR System is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K211866.

When did Bencox THR System receive FDA 510(k) clearance?

Bencox THR System received FDA 510(k) clearance on 2021-07-14, under 510(k) number K211866.

Who is the listed applicant for Bencox THR System?

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

What is the FDA product code for Bencox THR System?

The FDA product code for Bencox THR System is LPH.

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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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