第二意見® CS
K 號：K243234 · 2025-06-12
廣告
器材摘要
Second Opinion® CS is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K243234. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Second Opinion® CS?
Second Opinion® CS is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Pearl, Inc.. The 510(k) number is K243234.
When did Second Opinion® CS receive FDA 510(k) clearance?
Second Opinion® CS received FDA 510(k) clearance on 2025-06-12, under 510(k) number K243234.
Who is the listed applicant for Second Opinion® CS?
The FDA 510(k) record lists Pearl, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Second Opinion® CS?
The FDA product code for Second Opinion® CS is MYN.
相關臨床試驗
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。
其他以 Pearl, Inc. 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。
相關器械（代碼：MYN）
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。
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。
廣告