FDA 510(k)

OCM-G1 连接件

K号: K180063 · 2018-03-27

决定日期2018-03-27

产品代码ERL

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决定实质等同

器械摘要

OCM-G1 Attachment is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2018-03-27 under 510(k) number K180063. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OCM-G1 Attachment?

OCM-G1 Attachment is a medical device that received FDA 510(k) clearance on 2018-03-27. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K180063.

When did OCM-G1 Attachment receive FDA 510(k) clearance?

OCM-G1 Attachment received FDA 510(k) clearance on 2018-03-27, under 510(k) number K180063.

Who is the listed applicant for OCM-G1 Attachment?

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

What is the FDA product code for OCM-G1 Attachment?

The FDA product code for OCM-G1 Attachment is ERL.

列明The Anspach Effort, 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。

K220485无线手控装置，EG1A（WIRELESS-HC），无线手控装置接收器，EG1A（RECEIVER-HC）K183545Anspach螺旋解剖工具

官方来源

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