FDA 510(k)

Efficient Care 3D Planning

K号: K183544 · 2019-08-23

决定日期2019-08-23

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Efficient Care 3D Planning is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K183544. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Efficient Care 3D Planning?

Efficient Care 3D Planning is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K183544.

When did Efficient Care 3D Planning receive FDA 510(k) clearance?

Efficient Care 3D Planning received FDA 510(k) clearance on 2019-08-23, under 510(k) number K183544.

Who is the listed applicant for Efficient Care 3D Planning?

The FDA 510(k) record lists Orthosoft Inc (D/B/A Zimmer Cas) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Efficient Care 3D Planning?

The FDA product code for Efficient Care 3D Planning is LLZ.

列明Orthosoft Inc (D/B/A Zimmer Cas)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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