FDA 510(k)

Modulith SLX-F2

K 號：K201001 · 2021-03-30

決定日期2021-03-30

產品代碼LNS

諮詢委員會GU

決定相當於

器材摘要

Modulith SLX-F2 is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-03-30 under 510(k) number K201001. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Modulith SLX-F2?

Modulith SLX-F2 is a medical device that received FDA 510(k) clearance on 2021-03-30. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K201001.

When did Modulith SLX-F2 receive FDA 510(k) clearance?

Modulith SLX-F2 received FDA 510(k) clearance on 2021-03-30, under 510(k) number K201001.

Who is the listed applicant for Modulith SLX-F2?

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

What is the FDA product code for Modulith SLX-F2?

The FDA product code for Modulith SLX-F2 is LNS.

其他以 Karl Storz Endoscopy America 為申請人之記錄

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官方來源

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