FDA 510(k)

ELAN 4 Motor System

K号: K152960 · 2016-07-22

决定日期2016-07-22

产品代码HBC

咨询委员会NE

决定Substantially Equivalent

器械摘要

ELAN 4 Motor System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K152960. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELAN 4 Motor System?

ELAN 4 Motor System is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Aesculap, Inc.. The 510(k) number is K152960.

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

ELAN 4 Motor System received FDA 510(k) clearance on 2016-07-22, under 510(k) number K152960.

Who is the listed applicant for ELAN 4 Motor System?

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 Motor System?

The FDA product code for ELAN 4 Motor System is HBC.

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。

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