FDA 510(k)

Microdacyn 伤口护理溶液

K号: K233399 · 2024-09-13

决定日期2024-09-13

产品代码FRO

决定实质等同

器械摘要

Microdacyn Wound Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K233399. 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 Microdacyn Wound Care Solution?

Microdacyn Wound Care Solution is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K233399.

When did Microdacyn Wound Care Solution receive FDA 510(k) clearance?

Microdacyn Wound Care Solution received FDA 510(k) clearance on 2024-09-13, under 510(k) number K233399.

Who is the listed applicant for Microdacyn Wound Care Solution?

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

What is the FDA product code for Microdacyn Wound Care Solution?

The FDA product code for Microdacyn Wound Care Solution is FRO. This falls under the Anesthesiology category.

列明Sonoma Pharmaceuticals, 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。

K261023Microdacyn 伤口冲洗溶液 K240510Microdacyn 水凝胶 K173896Microcyn 抗菌水凝胶 K171935Alevicyn SG 抗菌凝胶 K172851Microcyn Plus 抗菌伤口护理溶液

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