Solea
K 號：K221761 · 2022-09-14
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器材摘要
Solea is the device name listed in this FDA 510(k) record. The listed applicant is Convergent Dental, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K221761. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Solea?
Solea is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Convergent Dental, Inc.. The 510(k) number is K221761.
When did Solea receive FDA 510(k) clearance?
Solea received FDA 510(k) clearance on 2022-09-14, under 510(k) number K221761.
Who is the listed applicant for Solea?
The FDA 510(k) record lists Convergent Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solea?
The FDA product code for Solea is NVK.
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相關器械（代碼：NVK）
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
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