斯匹羅-維斯塔
K 號：K253437 · 2026-06-12
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器材摘要
Spiro-VISTA is the device name listed in this FDA 510(k) record. The listed applicant is Spiro Robotics. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253437. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Spiro-VISTA?
Spiro-VISTA is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Spiro Robotics. The 510(k) number is K253437.
When did Spiro-VISTA receive FDA 510(k) clearance?
Spiro-VISTA received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253437.
Who is the listed applicant for Spiro-VISTA?
The FDA 510(k) record lists Spiro Robotics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Spiro-VISTA?
The FDA product code for Spiro-VISTA is BTR.
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：BTR）
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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