FDA 510(k)

ELAN 4 工具

K号: K182527 · 2019-01-19

决定日期2019-01-19

产品代码HBE

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决定实质等同

器械摘要

ELAN 4 Tools is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-01-19 under 510(k) number K182527. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELAN 4 Tools?

ELAN 4 Tools is a medical device that received FDA 510(k) clearance on 2019-01-19. The listed applicant is Aesculap, Inc.. The 510(k) number is K182527.

When did ELAN 4 Tools receive FDA 510(k) clearance?

ELAN 4 Tools received FDA 510(k) clearance on 2019-01-19, under 510(k) number K182527.

Who is the listed applicant for ELAN 4 Tools?

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

What is the FDA product code for ELAN 4 Tools?

The FDA product code for ELAN 4 Tools is HBE.

列明Aesculap, 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。

K242762Aesculap Aicon® 系列容器系统 K242003XABO 室间隔导管，XABO 腹膜导管，XABO 导管套装 K223596SQ.line KERRISON K214041Aesculap AICON 容器 K211572Aesculap Slim Clip Applier K203739ELAN 4 电动电机系统

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相关器械（代码：HBE）

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。

官方来源

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