諾瓦麥克斯創新eGFR監測系統
K 號：K251281 · 2026-01-21
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器材摘要
Nova Max Creat eGFR Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K251281. The device is classified under product code SHB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Nova Max Creat eGFR Monitoring System?
Nova Max Creat eGFR Monitoring System is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K251281.
When did Nova Max Creat eGFR Monitoring System receive FDA 510(k) clearance?
Nova Max Creat eGFR Monitoring System received FDA 510(k) clearance on 2026-01-21, under 510(k) number K251281.
Who is the listed applicant for Nova Max Creat eGFR Monitoring System?
The FDA 510(k) record lists Nova Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nova Max Creat eGFR Monitoring System?
The FDA product code for Nova Max Creat eGFR Monitoring System is SHB.
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其他以 Nova Biomedical Corporation 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。
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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