FDA 510(k)

DEKA SMARTPERIO

K号: K213658 · 2022-03-11

决定日期2022-03-11

产品代码NVK

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决定实质等同

器械摘要

DEKA SMARTPERIO is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213658. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DEKA SMARTPERIO?

DEKA SMARTPERIO is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K213658.

When did DEKA SMARTPERIO receive FDA 510(k) clearance?

DEKA SMARTPERIO received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213658.

Who is the listed applicant for DEKA SMARTPERIO?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA SMARTPERIO?

The FDA product code for DEKA SMARTPERIO is NVK.

列明El.En Electronic Engineering Spa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。

K222221DEKA HELIX K212270DEKA LipoAI K211091Deka Tiac II K211362SCAR 3 K203396DEKA SMARTPERIO K211821DEKA Motus AZ

查看所有 17 个设备 →

相关器械（代码：NVK）

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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官方来源

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