FDA 510(k)

EM 临时

K号: K191751 · 2019-12-16

决定日期2019-12-16

产品代码DZE

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决定实质等同

器械摘要

EM Provisional is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K191751. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EM Provisional?

EM Provisional is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Hiossen, Inc.. The 510(k) number is K191751.

When did EM Provisional receive FDA 510(k) clearance?

EM Provisional received FDA 510(k) clearance on 2019-12-16, under 510(k) number K191751.

Who is the listed applicant for EM Provisional?

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

What is the FDA product code for EM Provisional?

The FDA product code for EM Provisional is DZE.

列明Hiossen, 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。

K253372ET修复连接体；ET扫描修复连接体；EK扫描修复连接体 K251427EK MULTI ANGLED 30 基台 K241003HIOSSEN 预加工基台（ET 预加工基台 & EK 预加工基台）K240232EK D3.3 和超宽植入物 K233389EK 数字基台 K222636ET连接体系统

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官方来源

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