FDA 510(k)

V.A.C.ULTA 负压伤口治疗系统

K号: K162790 · 2017-01-26

申请人Kci USA, Inc. (Kinetic Concepts, Inc.)

决定日期2017-01-26

产品代码OMP

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决定实质等同

器械摘要

V.A.C.ULTA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K162790. 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 V.A.C.ULTA Negative Pressure Wound Therapy System?

V.A.C.ULTA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K162790.

When did V.A.C.ULTA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

V.A.C.ULTA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-01-26, under 510(k) number K162790.

Who is the listed applicant for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Kci USA, Inc. (Kinetic Concepts, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System is OMP.

列明Kci USA, Inc. (Kinetic Concepts, 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。

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