FDA 510(k)

Atteris 抗菌皮肤保护剂

K号: K161212 · 2016-09-30

决定日期2016-09-30

产品代码FRO

决定实质等同

器械摘要

Atteris Antimicrobial Skin Protectant is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161212. 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 Atteris Antimicrobial Skin Protectant?

Atteris Antimicrobial Skin Protectant is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Rochal Industries, LLC. The 510(k) number is K161212.

When did Atteris Antimicrobial Skin Protectant receive FDA 510(k) clearance?

Atteris Antimicrobial Skin Protectant received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161212.

Who is the listed applicant for Atteris Antimicrobial Skin Protectant?

The FDA 510(k) record lists Rochal Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atteris Antimicrobial Skin Protectant?

The FDA product code for Atteris Antimicrobial Skin Protectant is FRO. This falls under the Anesthesiology category.

列明Rochal Industries, LLC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。

K192527Rochal抗菌伤口凝胶 K182733Rochal生物防护硅酮薄膜 K160192Atteris 抗菌皮肤和伤口清洁剂 K160684Atteris 无痛皮肤保护剂

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