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FDA 510(k)

一次性內視鏡閥門組，一次性內視鏡閥門組 B

K 號：K200769 · 2021-01-06

申請人Wilson Instruments (Sha) Co., Ltd.
決定日期2021-01-06
產品代碼ODC
諮詢委員會GU
決定相當於

器材摘要

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B is the device name listed in this FDA 510(k) record. The listed applicant is Wilson Instruments (Sha) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200769. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B?

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Wilson Instruments (Sha) Co., Ltd.. The 510(k) number is K200769.

When did Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B receive FDA 510(k) clearance?

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200769.

Who is the listed applicant for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B?

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

What is the FDA product code for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B?

The FDA product code for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B is ODC.

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