FDA 510(k)

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K号: K161138 · 2016-07-20

决定日期2016-07-20

产品代码OAN

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决定实质等同

器械摘要

St. Louis Band is the device name listed in this FDA 510(k) record. The listed applicant is Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K161138. The device is classified under product code OAN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the St. Louis Band?

St. Louis Band is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Orthomerica Products, Inc.. The 510(k) number is K161138.

When did St. Louis Band receive FDA 510(k) clearance?

St. Louis Band received FDA 510(k) clearance on 2016-07-20, under 510(k) number K161138.

Who is the listed applicant for St. Louis Band?

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

What is the FDA product code for St. Louis Band?

The FDA product code for St. Louis Band is OAN.

列明Orthomerica Products, 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。

K240466STARband 3D K223238STARband 3D K211376STARband K203098STARband, STARlight, St. Louis Band K180109STARband, STARlight, St. Louis Band

官方来源

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