FDA 510(k)

PHMB 抗菌泡沫伤口敷料

K号: K163062 · 2017-07-25

决定日期2017-07-25

产品代码FRO

决定实质等同

器械摘要

PHMB Antimicrobial Foam Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K163062. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the PHMB Antimicrobial Foam Wound Dressing?

PHMB Antimicrobial Foam Wound Dressing is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K163062.

When did PHMB Antimicrobial Foam Wound Dressing receive FDA 510(k) clearance?

PHMB Antimicrobial Foam Wound Dressing received FDA 510(k) clearance on 2017-07-25, under 510(k) number K163062.

Who is the listed applicant for PHMB Antimicrobial Foam Wound Dressing?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHMB Antimicrobial Foam Wound Dressing?

The FDA product code for PHMB Antimicrobial Foam Wound Dressing is FRO. This falls under the Anesthesiology category.

列明Advanced Medical Solutions, Ltd.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。

K213473含PHMB的抗菌凝胶纤维敷料 K210974高性能抗菌凝胶纤维（含银）K190819硅胶PHMB泡沫伤口敷料 K183645高性能银敷料 K180634外科银质术后敷料 K181197PHMB 泡沫伤口敷料

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