FDA 510(k)

STARband 3D

K号: K240466 · 2024-03-15

决定日期2024-03-15

产品代码OAN

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决定实质等同

器械摘要

STARband 3D 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 2024-03-15 under 510(k) number K240466. 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 STARband 3D?

STARband 3D is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Orthomerica Products, Inc.. The 510(k) number is K240466.

When did STARband 3D receive FDA 510(k) clearance?

STARband 3D received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240466.

Who is the listed applicant for STARband 3D?

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 STARband 3D?

The FDA product code for STARband 3D 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。

K223238STARband 3D K211376STARband K203098STARband, STARlight, St. Louis Band K180109STARband, STARlight, St. Louis Band K161138圣路易斯带

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