FDA 510(k)

OTELO LL

K号: K151104 · 2016-01-06

决定日期2016-01-06

产品代码GAD

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决定实质等同

器械摘要

OTELO LL is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K151104. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OTELO LL?

OTELO LL is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Spineart. The 510(k) number is K151104.

When did OTELO LL receive FDA 510(k) clearance?

OTELO LL received FDA 510(k) clearance on 2016-01-06, under 510(k) number K151104.

Who is the listed applicant for OTELO LL?

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

What is the FDA product code for OTELO LL?

The FDA product code for OTELO LL is GAD.

列明Spineart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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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。