FDA 510(k)

PICO 单次使用负压伤口治疗系统

K号: K151436 · 2016-01-28

决定日期2016-01-28

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, Ltd.. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K151436. 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 2016-01-28. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K151436.

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 2016-01-28, under 510(k) number K151436.

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

FDA 510(k)记录将史密斯·奈普医疗有限公司列为申请人。这本身并不能确立该设备的制造商。

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, Ltd.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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官方来源

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