耳鼻喉生物技術解決方案組織移除設備（ELASSO）
K 號：K152702 · 2016-02-18
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器材摘要
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is the device name listed in this FDA 510(k) record. The listed applicant is Ent Biotech Solutions. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K152702. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Ent Biotech Solutions. The 510(k) number is K152702.
When did ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) receive FDA 510(k) clearance?
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) received FDA 510(k) clearance on 2016-02-18, under 510(k) number K152702.
Who is the listed applicant for ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?
The FDA 510(k) record lists Ent Biotech Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?
The FDA product code for ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is GEI.
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。
相關器械（代碼：GEI）
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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