FDA 510(k)

PWD 负压伤口治疗系统

K号: K212359 · 2022-09-21

决定日期2022-09-21

产品代码OMP

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决定实质等同

器械摘要

PWD Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K212359. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PWD Negative Pressure Wound Therapy System?

PWD Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K212359.

When did PWD Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PWD Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-09-21, under 510(k) number K212359.

Who is the listed applicant for PWD Negative Pressure Wound Therapy System?

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

What is the FDA product code for PWD Negative Pressure Wound Therapy System?

The FDA product code for PWD Negative Pressure Wound Therapy System is OMP.

列明Applied Tissue Technologies, 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。

K191460PWD 平台伤口敷料 3" x 5" 扁平 K182409应用组织技术PWD™平台伤口敷料

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