Ova+ (K-OVAP-USA)
K 號：K230926 · 2023-12-15
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器材摘要
Ova+ (K-OVAP-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 2023-12-15 under 510(k) number K230926. 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 Ova+ (K-OVAP-USA)?
Ova+ (K-OVAP-USA) is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Tenscare, Ltd.. The 510(k) number is K230926.
When did Ova+ (K-OVAP-USA) receive FDA 510(k) clearance?
Ova+ (K-OVAP-USA) received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230926.
Who is the listed applicant for Ova+ (K-OVAP-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 Ova+ (K-OVAP-USA)?
The FDA product code for Ova+ (K-OVAP-USA) is NUH.
其他以 Tenscare, Ltd. 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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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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