狼445nm
K 號：K192272 · 2020-03-17
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器材摘要
Wolf445nm is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K192272. 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 Wolf445nm?
Wolf445nm is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K192272.
When did Wolf445nm receive FDA 510(k) clearance?
Wolf445nm received FDA 510(k) clearance on 2020-03-17, under 510(k) number K192272.
Who is the listed applicant for Wolf445nm?
The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wolf445nm?
The FDA product code for Wolf445nm is GEX. This falls under the Gastroenterology category.
其他以 A.R.C Laser GmbH 為申請人之記錄
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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
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