FDA 510(k)

ERBEFLO 2 一次性管路系统

K号: K190469 · 2019-05-23

决定日期2019-05-23

产品代码OCX

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决定实质等同

器械摘要

ERBEFLO 2 Disposable Tubing System 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 2019-05-23 under 510(k) number K190469. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ERBEFLO 2 Disposable Tubing System?

ERBEFLO 2 Disposable Tubing System is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Erbe USA, Inc.. The 510(k) number is K190469.

When did ERBEFLO 2 Disposable Tubing System receive FDA 510(k) clearance?

ERBEFLO 2 Disposable Tubing System received FDA 510(k) clearance on 2019-05-23, under 510(k) number K190469.

Who is the listed applicant for ERBEFLO 2 Disposable Tubing System?

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 Disposable Tubing System?

The FDA product code for ERBEFLO 2 Disposable Tubing System is OCX.

列明Erbe USA, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221177Erbe 的管/盖套装 K191438ERBEFLO 2 内窥镜快速连接宾得镜头端口连接器 K182444ERBEFLO Olympus 镜头端口连接器 K162152Erbe 的 CO2 管/盖套装

官方来源

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