FDA 510(k)

UNO 负压伤口治疗系统

K号: K221891 · 2022-12-14

决定日期2022-12-14

产品代码OMP

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决定实质等同

器械摘要

UNO Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K221891. 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 UNO Negative Pressure Wound Therapy System?

UNO Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K221891.

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

UNO Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-12-14, under 510(k) number K221891.

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

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

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

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

列明Genadyne Biotechnologies, 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。

K253429Genadyne ASTRA NPWT K243225鼻枕面罩 - 小型（NNPM-01/ Nefes S）；鼻枕面罩 - 中型（NNPM-02/ Nefes M）；鼻枕面罩 - 大型（NNPM-03/ Nefes L）K233614Genadyne DUO NPWT K221888Genadyne 混合泡沫敷料 K210107Genadyne UNO Plus (UNO+) 负压伤口治疗系统 K180840UNO 负压伤口治疗系统

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官方来源

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