PALLAS 頂級
K 號：K223588 · 2023-01-26
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器材摘要
PALLAS Premium is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K223588. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the PALLAS Premium?
PALLAS Premium is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K223588.
When did PALLAS Premium receive FDA 510(k) clearance?
PALLAS Premium received FDA 510(k) clearance on 2023-01-26, under 510(k) number K223588.
Who is the listed applicant for PALLAS Premium?
The FDA 510(k) record lists Laseroptek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PALLAS Premium?
The FDA product code for PALLAS Premium is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 Laseroptek Co., Ltd. 為申請人之記錄
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：GEX）
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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