FDA 510(k)

PICO 单次使用负压伤口治疗系统

K号: K163387 · 2017-04-18

决定日期2017-04-18

产品代码OMP

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决定实质等同

器械摘要

PICO 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 2017-04-18 under 510(k) number K163387. 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 Single Use Negative Pressure Wound Therapy System?

PICO Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K163387.

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

PICO Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-04-18, under 510(k) number K163387.

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

The FDA product code for PICO 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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