FDA 510(k)

Hydrocleanse 抗菌皮肤和伤口护理溶液

K号: K171727 · 2017-07-26

决定日期2017-07-26

产品代码FRO

决定实质等同

器械摘要

Hydrocleanse Antimicrobial Skin and Wound Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K171727. 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 Hydrocleanse Antimicrobial Skin and Wound Care Solution?

Hydrocleanse Antimicrobial Skin and Wound Care Solution is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Sonoma Pharmaceuticals. The 510(k) number is K171727.

When did Hydrocleanse Antimicrobial Skin and Wound Care Solution receive FDA 510(k) clearance?

Hydrocleanse Antimicrobial Skin and Wound Care Solution received FDA 510(k) clearance on 2017-07-26, under 510(k) number K171727.

Who is the listed applicant for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

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

What is the FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

The FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution is FRO. This falls under the Anesthesiology category.

列明Sonoma Pharmaceuticals为申报人的其他记录

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K172622Microcyn 抗菌皮肤和伤口清洁剂

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