FDA 510(k)

Synergy Marble（型号：Opasm）

K号: K220064 · 2022-07-22

决定日期2022-07-22

产品代码OHS

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决定实质等同

器械摘要

Synergy Marble (Model: Opasm) is the device name listed in this FDA 510(k) record. The listed applicant is Yrs Group, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K220064. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Synergy Marble (Model: Opasm)?

Synergy Marble (Model: Opasm) is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Yrs Group, Inc.. The 510(k) number is K220064.

When did Synergy Marble (Model: Opasm) receive FDA 510(k) clearance?

Synergy Marble (Model: Opasm) received FDA 510(k) clearance on 2022-07-22, under 510(k) number K220064.

Who is the listed applicant for Synergy Marble (Model: Opasm)?

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

What is the FDA product code for Synergy Marble (Model: Opasm)?

The FDA product code for Synergy Marble (Model: Opasm) is OHS.

列明Yrs Group, 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。

K210954Synergy

相关器械（代码：OHS）

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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