OPTIS金屬支架優化 E.4 SW
K 號：K160878 · 2016-06-29
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器材摘要
OPTIS Metallic Stent Optimization E.4 SW is the device name listed in this FDA 510(k) record. The listed applicant is Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160878. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OPTIS Metallic Stent Optimization E.4 SW?
OPTIS Metallic Stent Optimization E.4 SW is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Lightlab Imaging, Inc.. The 510(k) number is K160878.
When did OPTIS Metallic Stent Optimization E.4 SW receive FDA 510(k) clearance?
OPTIS Metallic Stent Optimization E.4 SW received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160878.
Who is the listed applicant for OPTIS Metallic Stent Optimization E.4 SW?
The FDA 510(k) record lists Lightlab Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPTIS Metallic Stent Optimization E.4 SW?
The FDA product code for OPTIS Metallic Stent Optimization E.4 SW is NQQ.
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相關器械（代碼：NQQ）
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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