RHEA生命徵象監控系統
K 號：K190775 · 2019-12-19
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器材摘要
The RHEA Vital Sign Vigilance System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fiber Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190775. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the The RHEA Vital Sign Vigilance System?
The RHEA Vital Sign Vigilance System is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Shenzhen Fiber Medical Technology Co. , Ltd.. The 510(k) number is K190775.
When did The RHEA Vital Sign Vigilance System receive FDA 510(k) clearance?
The RHEA Vital Sign Vigilance System received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190775.
Who is the listed applicant for The RHEA Vital Sign Vigilance System?
The FDA 510(k) record lists Shenzhen Fiber Medical Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The RHEA Vital Sign Vigilance System?
The FDA product code for The RHEA Vital Sign Vigilance System is BZQ.
相關臨床試驗
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相關器械（代碼：BZQ）
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。
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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