FDA 510(k)

Bodygard SFS 外科手术服 Level 3

K号: K202845 · 2022-02-24

申请人Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

决定日期2022-02-24

产品代码FYA

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决定实质等同

器械摘要

Bodygard SFS Surgical Gown Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K202845. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bodygard SFS Surgical Gown Level 3?

Bodygard SFS Surgical Gown Level 3 is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. The 510(k) number is K202845.

When did Bodygard SFS Surgical Gown Level 3 receive FDA 510(k) clearance?

Bodygard SFS Surgical Gown Level 3 received FDA 510(k) clearance on 2022-02-24, under 510(k) number K202845.

Who is the listed applicant for Bodygard SFS Surgical Gown Level 3?

The FDA 510(k) record lists Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bodygard SFS Surgical Gown Level 3?

The FDA product code for Bodygard SFS Surgical Gown Level 3 is FYA.

列明Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi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。

K212111Myflon 医用外科口罩 Level 3

相关器械（代码：FYA）

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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