FDA 510(k)

MyNeWT 負壓創面治療系統

K 號：K161432 · 2017-02-08

決定日期2017-02-08

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

MyNeWT Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Stortford Medical, LLC. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K161432. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MyNeWT Negative Pressure Wound Therapy System?

MyNeWT Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Stortford Medical, LLC. The 510(k) number is K161432.

When did MyNeWT Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

MyNeWT Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-02-08, under 510(k) number K161432.

Who is the listed applicant for MyNeWT Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Stortford Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MyNeWT Negative Pressure Wound Therapy System?

The FDA product code for MyNeWT Negative Pressure Wound Therapy System is OMP.

相關器械（代碼：OMP）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OMP）

官方來源