FDA 510(k)

ERBEFLO 2 結合快速連接式 Pentax 結腸鏡端口連接器

K 號：K191438 · 2019-06-27

決定日期2019-06-27

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K191438. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector?

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Erbe USA, Inc.. The 510(k) number is K191438.

When did ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector receive FDA 510(k) clearance?

ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector received FDA 510(k) clearance on 2019-06-27, under 510(k) number K191438.

Who is the listed applicant for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector?

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

What is the FDA product code for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector?

The FDA product code for ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector is OCX.

其他以 Erbe USA, Inc. 為申請人之記錄

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。

K221177Erbe的管子/蓋子組 K190469ERBEFLO 2 一次性管路系統 K182444ERBEFLO 奧林巴斯鏡頭端口連接器 K162152Erbe的CO2管/蓋組

相關器械（代碼：OCX）

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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官方來源

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