FDA 510(k)

PWD 負壓創傷治療系統

K 號：K212359 · 2022-09-21

決定日期2022-09-21

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

PWD Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K212359. 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 PWD Negative Pressure Wound Therapy System?

PWD Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K212359.

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

PWD Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-09-21, under 510(k) number K212359.

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

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

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

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

其他以 Applied Tissue Technologies, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：OMP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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