FDA 510(k)

PICO 7Y 单次使用负压伤口治疗系统

K号: K182323 · 2019-01-18

决定日期2019-01-18

产品代码OMP

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决定实质等同

器械摘要

PICO 7Y 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 2019-01-18 under 510(k) number K182323. 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 7Y Single Use Negative Pressure Wound Therapy System?

PICO 7Y Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K182323.

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

PICO 7Y Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182323.

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

The FDA product code for PICO 7Y 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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