FDA 510(k)

Dukal Corporation AAMI Level 4 开放式背部防护服

K号: K212464 · 2022-03-30

决定日期2022-03-30

产品代码QPC

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决定实质等同

器械摘要

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K212464. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Dukal Corporation. The 510(k) number is K212464.

When did Dukal Corporation AAMI Level 4 Open-Back Protective Gown receive FDA 510(k) clearance?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown received FDA 510(k) clearance on 2022-03-30, under 510(k) number K212464.

Who is the listed applicant for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

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

What is the FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

The FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown is QPC.

列明Dukal Corporation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。

K210321Dukal Corporation Level 1 儿科面部口罩 K203237Dukal AAMI 级别 3 灭菌手术服，AAMI 级别 3 手术服，AAMI 级别 4 手术服，以及 AAMI 级别 4 焊接手术服 K201732Dukal Corporation Level 3 带耳环的手术口罩，Dukal Corporation Level 3 带系带的手术口罩 K201421Dukal Corporation Level 2 带耳环的手术口罩；Dukal Corporation Level 2 带耳环和面罩的手术口罩；Dukal Corporation Level 2 可调节系带的手术口罩

官方来源

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