FDA 510(k)

MOVIX DReamy

K号: K212515 · 2021-11-03

决定日期2021-11-03

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

MOVIX DReamy is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K212515. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MOVIX DReamy?

MOVIX DReamy is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Stephanix. The 510(k) number is K212515.

When did MOVIX DReamy receive FDA 510(k) clearance?

MOVIX DReamy received FDA 510(k) clearance on 2021-11-03, under 510(k) number K212515.

Who is the listed applicant for MOVIX DReamy?

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

What is the FDA product code for MOVIX DReamy?

The FDA product code for MOVIX DReamy is IZL.

列明Stephanix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。

K221335D²RS 和 D²RS 9090 K213479D²RS 和 D²RS 9090

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