FDA 510(k)

TCD-X

K号: K182175 · 2019-04-05

申请人Atys

决定日期2019-04-05

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

TCD-X is the device name listed in this FDA 510(k) record. The listed applicant is Atys. It received FDA 510(k) clearance on 2019-04-05 under 510(k) number K182175. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TCD-X?

TCD-X is a medical device that received FDA 510(k) clearance on 2019-04-05. The listed applicant is Atys. The 510(k) number is K182175.

When did TCD-X receive FDA 510(k) clearance?

TCD-X received FDA 510(k) clearance on 2019-04-05, under 510(k) number K182175.

Who is the listed applicant for TCD-X?

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

What is the FDA product code for TCD-X?

The FDA product code for TCD-X is IYN.

相关器械（代码：IYN）

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