Skylit 光療系統
K 號：K170489 · 2017-05-23
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器材摘要
Skylit Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Skylit Medical. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K170489. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Skylit Phototherapy System?
Skylit Phototherapy System is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Skylit Medical. The 510(k) number is K170489.
When did Skylit Phototherapy System receive FDA 510(k) clearance?
Skylit Phototherapy System received FDA 510(k) clearance on 2017-05-23, under 510(k) number K170489.
Who is the listed applicant for Skylit Phototherapy System?
The FDA 510(k) record lists Skylit Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Skylit Phototherapy System?
The FDA product code for Skylit Phototherapy System is FTC.
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：FTC）
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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