SKIA-Head（型號：SKIA-ST00）
K 號：K253486 · 2026-02-23
廣告
器材摘要
SKIA-Head (Model: SKIA-ST00) is the device name listed in this FDA 510(k) record. The listed applicant is Skia, Inc.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253486. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SKIA-Head (Model: SKIA-ST00)?
SKIA-Head (Model: SKIA-ST00) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Skia, Inc.. The 510(k) number is K253486.
When did SKIA-Head (Model: SKIA-ST00) receive FDA 510(k) clearance?
SKIA-Head (Model: SKIA-ST00) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253486.
Who is the listed applicant for SKIA-Head (Model: SKIA-ST00)?
The FDA 510(k) record lists Skia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SKIA-Head (Model: SKIA-ST00)?
The FDA product code for SKIA-Head (Model: SKIA-ST00) is LLZ.
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：LLZ）
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