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FDA 510(k)

Spectricept 皮肤和伤口清洁剂

K号: K213514 · 2023-01-13

申请人Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
决定日期2023-01-13
产品代码FRO
决定实质等同

器械摘要

Spectricept Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K213514. 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 Spectricept Skin and Wound Cleanser?

Spectricept Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. The 510(k) number is K213514.

When did Spectricept Skin and Wound Cleanser receive FDA 510(k) clearance?

Spectricept Skin and Wound Cleanser received FDA 510(k) clearance on 2023-01-13, under 510(k) number K213514.

Who is the listed applicant for Spectricept Skin and Wound Cleanser?

The FDA 510(k) record lists Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spectricept Skin and Wound Cleanser?

The FDA product code for Spectricept Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FRO）

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。

K254168Actolind®（06.3637. Actolind®凝胶加强型）ACTO GmbHK254041SkinSmart 抗菌保湿凝胶Magic Science Supply, LLCK261646Redermax® 抗菌伤口基质Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌伤口凝胶Silverceuticals, Inc.K261023Microdacyn 伤口冲洗溶液Sonoma Pharmaceuticals, Inc.

官方来源

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