精準SHP二極雷射
K 號：K181601 · 2019-09-09
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器材摘要
Precise SHP Diode Laser is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2019-09-09 under 510(k) number K181601. 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 Precise SHP Diode Laser?
Precise SHP Diode Laser is a medical device that received FDA 510(k) clearance on 2019-09-09. The listed applicant is CAO Group, Inc.. The 510(k) number is K181601.
When did Precise SHP Diode Laser receive FDA 510(k) clearance?
Precise SHP Diode Laser received FDA 510(k) clearance on 2019-09-09, under 510(k) number K181601.
Who is the listed applicant for Precise SHP Diode Laser?
The FDA 510(k) record lists CAO Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Precise SHP Diode Laser?
The FDA product code for Precise SHP Diode Laser is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 CAO Group, Inc. 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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