FDA 510(k)

MyCRO Band

K号: K213587 · 2022-06-09

决定日期2022-06-09

产品代码MVA

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决定实质等同

器械摘要

MyCRO Band is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare LP. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K213587. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MyCRO Band?

MyCRO Band is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K213587.

When did MyCRO Band receive FDA 510(k) clearance?

MyCRO Band received FDA 510(k) clearance on 2022-06-09, under 510(k) number K213587.

Who is the listed applicant for MyCRO Band?

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

What is the FDA product code for MyCRO Band?

The FDA product code for MyCRO Band is MVA.

列明Otto Bock Healthcare LP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。

K201426MyCRO Band

官方来源

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