FDA 510(k)

T-SHAPE 2

K番号: K231092 · 2023-09-22

決定日2023-09-22

製品コードNUV

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

T-SHAPE 2 is the device name listed in this FDA 510(k) record. The listed applicant is B&M S.R.L. Marketing Nel Benessere. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231092. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the T-SHAPE 2?

T-SHAPE 2 is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is B&M S.R.L. Marketing Nel Benessere. The 510(k) number is K231092.

When did T-SHAPE 2 receive FDA 510(k) clearance?

T-SHAPE 2 received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231092.

Who is the listed applicant for T-SHAPE 2?

The FDA 510(k) record lists B&M S.R.L. Marketing Nel Benessere as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-SHAPE 2?

The FDA product code for T-SHAPE 2 is NUV.

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T-SHAPE 2

医療機器の概要

よくある質問

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