FDA 510(k)

內視鏡（21033FA、21033FC、21033WA、21033WC、20533FA、20533FC、20533WA、20533WC）

K 號：K231003 · 2023-07-06

申請人Guangdong Optomedic Technologies, Inc.

決定日期2023-07-06

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K231003. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)?

Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K231003.

When did Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) receive FDA 510(k) clearance?

Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) received FDA 510(k) clearance on 2023-07-06, under 510(k) number K231003.

Who is the listed applicant for Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)?

The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)?

The FDA product code for Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) is GCJ.

其他以 Guangdong Optomedic Technologies, Inc. 為申請人之記錄

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相關器械（代碼：GCJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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