FDA 510(k)

TGS 通用头枕带安装臂

K号: K193502 · 2020-02-14

决定日期2020-02-14

产品代码PGW

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决定实质等同

器械摘要

TGS Universal Headrest with Mounting Arm is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Ent. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K193502. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TGS Universal Headrest with Mounting Arm?

TGS Universal Headrest with Mounting Arm is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Stryker Ent. The 510(k) number is K193502.

When did TGS Universal Headrest with Mounting Arm receive FDA 510(k) clearance?

TGS Universal Headrest with Mounting Arm received FDA 510(k) clearance on 2020-02-14, under 510(k) number K193502.

Who is the listed applicant for TGS Universal Headrest with Mounting Arm?

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

What is the FDA product code for TGS Universal Headrest with Mounting Arm?

The FDA product code for TGS Universal Headrest with Mounting Arm is PGW.

列明Stryker Ent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。

K201398SINUSPRIME 扩张系统 K193118TGS 导丝和更新后的 Scopis 软件

相关器械（代码：PGW）

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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