肯茲卡迪科1211
K 號：K172068 · 2018-06-01
廣告
器材摘要
Kenz Cardico1211 is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K172068. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Kenz Cardico1211?
Kenz Cardico1211 is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K172068.
When did Kenz Cardico1211 receive FDA 510(k) clearance?
Kenz Cardico1211 received FDA 510(k) clearance on 2018-06-01, under 510(k) number K172068.
Who is the listed applicant for Kenz Cardico1211?
The FDA 510(k) record lists Suzuken Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kenz Cardico1211?
The FDA product code for Kenz Cardico1211 is DPS.
相關臨床試驗
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。
相關器械（代碼：DPS）
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。
K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs 霍爾特平台Philips France Commercial
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。
廣告