FDA 510(k)

Unicare (K-UNICARE-USA)

K 號：K231053 · 2023-08-18

決定日期2023-08-18

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

Unicare (K-UNICARE-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231053. 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 Unicare (K-UNICARE-USA)?

Unicare (K-UNICARE-USA) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Tenscare, Ltd.. The 510(k) number is K231053.

When did Unicare (K-UNICARE-USA) receive FDA 510(k) clearance?

Unicare (K-UNICARE-USA) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231053.

Who is the listed applicant for Unicare (K-UNICARE-USA)?

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

What is the FDA product code for Unicare (K-UNICARE-USA)?

The FDA product code for Unicare (K-UNICARE-USA) is NUH.

其他以 Tenscare, 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。

K232441Unipro (K-UNIPRO-US)K230926Ova+ (K-OVAP-USA)K230983Unicare (K-UNICARE-USA)K200694完美電子肌肉刺激器 FDA、510(k)、PMA、NCT、PMID、識別碼及網址請參考原文。K191312完美PFE

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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