BIOMONITOR IIIm, BIOMONITOR III
K 號：K221856 · 2022-07-27
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器材摘要
BIOMONITOR IIIm, BIOMONITOR III is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K221856. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BIOMONITOR IIIm, BIOMONITOR III?
BIOMONITOR IIIm, BIOMONITOR III is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Biotronik, Inc.. The 510(k) number is K221856.
When did BIOMONITOR IIIm, BIOMONITOR III receive FDA 510(k) clearance?
BIOMONITOR IIIm, BIOMONITOR III received FDA 510(k) clearance on 2022-07-27, under 510(k) number K221856.
Who is the listed applicant for BIOMONITOR IIIm, BIOMONITOR III?
The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIOMONITOR IIIm, BIOMONITOR III?
The FDA product code for BIOMONITOR IIIm, BIOMONITOR III is MXD.
相關臨床試驗
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其他以 Biotronik, Inc. 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。
K261074BIOMONITOR IV (471155)K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterK242969Pantera Pro; Pantera LEOK240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)K241711Oscar Peripheral Multifunctional Catheter systemK230375BIOMONITOR IV
相關器械（代碼：MXD）
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。
K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICALK251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)AbbottK252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific CorporationK240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.
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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