FDA 510(k)

頸部護理治療，型號：AST-905A，AST-905D，AST-905H

K 號：K210756 · 2021-06-11

申請人Shenzhen Osto Technology Company Limited

決定日期2021-06-11

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

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210756. 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 Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K210756.

When did Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H receive FDA 510(k) clearance?

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210756.

Who is the listed applicant for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

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

What is the FDA product code for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

The FDA product code for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is NUH.

其他以 Shenzhen Osto Technology Company Limited 為申請人之記錄

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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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