invisa-RED ELITE
K 號：K192275 · 2020-08-19
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器材摘要
invisa-RED ELITE is the device name listed in this FDA 510(k) record. The listed applicant is IR Technology, LLC. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K192275. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the invisa-RED ELITE?
invisa-RED ELITE is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is IR Technology, LLC. The 510(k) number is K192275.
When did invisa-RED ELITE receive FDA 510(k) clearance?
invisa-RED ELITE received FDA 510(k) clearance on 2020-08-19, under 510(k) number K192275.
Who is the listed applicant for invisa-RED ELITE?
The FDA 510(k) record lists IR Technology, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for invisa-RED ELITE?
The FDA product code for invisa-RED ELITE is OLI.
相關臨床試驗
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相關器械（代碼：OLI）
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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