FDA 510(k)

防霧系統範圍

K 號：K182080 · 2018-09-19

決定日期2018-09-19

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Scope Antifogging System is the device name listed in this FDA 510(k) record. The listed applicant is Xodus Medical, Inc.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K182080. 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 Scope Antifogging System?

Scope Antifogging System is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Xodus Medical, Inc.. The 510(k) number is K182080.

When did Scope Antifogging System receive FDA 510(k) clearance?

Scope Antifogging System received FDA 510(k) clearance on 2018-09-19, under 510(k) number K182080.

Who is the listed applicant for Scope Antifogging System?

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

What is the FDA product code for Scope Antifogging System?

The FDA product code for Scope Antifogging System is GCJ.

其他以 Xodus Medical, Inc. 為申請人之記錄

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K260903熱粉紅墊加熱系統

相關器械（代碼：GCJ）

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