FDA 510(k)

T-PLUS

K号: K181893 · 2019-01-29

决定日期2019-01-29

产品代码PBX

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决定实质等同

器械摘要

T-PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Wintecare SA. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K181893. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the T-PLUS?

T-PLUS is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Wintecare SA. The 510(k) number is K181893.

When did T-PLUS receive FDA 510(k) clearance?

T-PLUS received FDA 510(k) clearance on 2019-01-29, under 510(k) number K181893.

Who is the listed applicant for T-PLUS?

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

What is the FDA product code for T-PLUS?

The FDA product code for T-PLUS is PBX.

官方来源

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器械摘要

常见问题

相关器械（代码：PBX）

官方来源