mi-eye 2, mi-eye 2 監視器
K 號：K162475 · 2016-09-16
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器材摘要
mi-eye 2, mi-eye 2 monitor is the device name listed in this FDA 510(k) record. The listed applicant is Trice Medical. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K162475. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the mi-eye 2, mi-eye 2 monitor?
mi-eye 2, mi-eye 2 monitor is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Trice Medical. The 510(k) number is K162475.
When did mi-eye 2, mi-eye 2 monitor receive FDA 510(k) clearance?
mi-eye 2, mi-eye 2 monitor received FDA 510(k) clearance on 2016-09-16, under 510(k) number K162475.
Who is the listed applicant for mi-eye 2, mi-eye 2 monitor?
The FDA 510(k) record lists Trice Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for mi-eye 2, mi-eye 2 monitor?
The FDA product code for mi-eye 2, mi-eye 2 monitor is HRX.
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相關器械（代碼：HRX）
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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