FDA 510(k)

PICO 7 单次使用负压伤口治疗系统

K号: K180698 · 2018-08-21

决定日期2018-08-21

产品代码OMP

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决定实质等同

器械摘要

PICO 7 Single Use Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K180698. 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 PICO 7 Single Use Negative Pressure Wound Therapy System?

PICO 7 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K180698.

When did PICO 7 Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO 7 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-08-21, under 510(k) number K180698.

Who is the listed applicant for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System is OMP.

列明Smith & Nephew Medical Limited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。

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