FDA 510(k)

OW100S

K 號：K231710 · 2023-09-01

決定日期2023-09-01

產品代碼PZL

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

OW100S is the device name listed in this FDA 510(k) record. The listed applicant is Softwave/Trt, LLC. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231710. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OW100S?

OW100S is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Softwave/Trt, LLC. The 510(k) number is K231710.

When did OW100S receive FDA 510(k) clearance?

OW100S received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231710.

Who is the listed applicant for OW100S?

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

What is the FDA product code for OW100S?

The FDA product code for OW100S is PZL.

其他以 Softwave/Trt, 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。

K233937OW100S

相關器械（代碼：PZL）

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。

K243279DOLORCLAST 集中衝擊波E.M.S Electro Medical Systems S.A K250779CS-Pro醫療設備規範文本Curative Sound Therapeutics K233937OW100SSoftwave/Trt, LLC K202112Storz醫療 Duolith SD1 T-Top & Tower 系統搭配 C-Actor Sepia 手柄Storz Medical AG K200926OrthoGold 100Tissue Regeneration Technologies, LLC K191961正骨金Tissue Regeneration Technologies

官方來源

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