SIRIO H3
K 號：K163643 · 2017-11-16
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器材摘要
SIRIO H3 is the device name listed in this FDA 510(k) record. The listed applicant is Masmec Spa. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K163643. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SIRIO H3?
SIRIO H3 is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Masmec Spa. The 510(k) number is K163643.
When did SIRIO H3 receive FDA 510(k) clearance?
SIRIO H3 received FDA 510(k) clearance on 2017-11-16, under 510(k) number K163643.
Who is the listed applicant for SIRIO H3?
The FDA 510(k) record lists Masmec Spa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SIRIO H3?
The FDA product code for SIRIO H3 is JAK.
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相關器械（代碼：JAK）
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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