FDA 510(k)

低頻刺激器（型號：AST-645，AST-646）

K 號：K212989 · 2021-11-22

決定日期2021-11-22

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Low-frequency Stimulator (Model: AST-645, AST-646) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K212989. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Low-frequency Stimulator (Model: AST-645, AST-646)?

Low-frequency Stimulator (Model: AST-645, AST-646) is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K212989.

When did Low-frequency Stimulator (Model: AST-645, AST-646) receive FDA 510(k) clearance?

Low-frequency Stimulator (Model: AST-645, AST-646) received FDA 510(k) clearance on 2021-11-22, under 510(k) number K212989.

Who is the listed applicant for Low-frequency Stimulator (Model: AST-645, AST-646)?

The FDA 510(k) record lists Shenzhen Osto Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646)?

The FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646) is NUH.

其他以 Shenzhen Osto Technology Co., Ltd. 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：NUH）

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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