SPARK 扫描器
K 號：K231457 · 2023-08-18
廣告
器材摘要
SPARK Scan is the device name listed in this FDA 510(k) record. The listed applicant is Spark Neuro, Inc.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231457. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SPARK Scan?
SPARK Scan is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Spark Neuro, Inc.. The 510(k) number is K231457.
When did SPARK Scan receive FDA 510(k) clearance?
SPARK Scan received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231457.
Who is the listed applicant for SPARK Scan?
The FDA 510(k) record lists Spark Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SPARK Scan?
The FDA product code for SPARK Scan is GWQ.
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：GWQ）
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