FDA 510(k)

AMD Ritmed AssureWear VersaGown

K号: K190306 · 2020-01-17

决定日期2020-01-17

产品代码FYC

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决定实质等同

器械摘要

AMD Ritmed AssureWear VersaGown is the device name listed in this FDA 510(k) record. The listed applicant is Amd Medicom, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K190306. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AMD Ritmed AssureWear VersaGown?

AMD Ritmed AssureWear VersaGown is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Amd Medicom, Inc.. The 510(k) number is K190306.

When did AMD Ritmed AssureWear VersaGown receive FDA 510(k) clearance?

AMD Ritmed AssureWear VersaGown received FDA 510(k) clearance on 2020-01-17, under 510(k) number K190306.

Who is the listed applicant for AMD Ritmed AssureWear VersaGown?

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

What is the FDA product code for AMD Ritmed AssureWear VersaGown?

The FDA product code for AMD Ritmed AssureWear VersaGown is FYC.

列明Amd Medicom, 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。

K190308Medicom 安全口罩 Sofskin 儿童手术耳带口罩 (ASTM Level 1)，Medicom 安全口罩 Sofskin 儿童手术耳带口罩，Medicom 安全口罩 Premier 儿童手术耳带口罩 (ASTM Level 1)，Medicom 安全口罩 Premier 儿童手术耳带口罩 (ASTM Level 1)

相关器械（代码：FYC）

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。

K232849Halyard Tri-Layer AAMI 3隔离服，L，蓝色（54310），Halyard Tri-Layer AAMI 3隔离服，超大号，蓝色（54311）Owens & Minor (O&M) Halyard, Inc.K230135Copioumed 化疗隔离服Copioumed International, Inc.K223467一次性隔离服Nanning Tecbod Biological Technology Co., Ltd.K223304一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Technology Co., Ltd.K223411一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI等级3隔离服Paneffort, LLC

官方来源

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