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FDA 510(k)

BioMonitor 2-AF, BioMonitor 2-S

K号: K170628 · 2017-03-31

申请人Biotronik, Inc.
决定日期2017-03-31
产品代码MXD
咨询委员会CV
决定Substantially Equivalent

器械摘要

BioMonitor 2-AF, BioMonitor 2-S is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K170628. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioMonitor 2-AF, BioMonitor 2-S?

BioMonitor 2-AF, BioMonitor 2-S is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Biotronik, Inc.. The 510(k) number is K170628.

When did BioMonitor 2-AF, BioMonitor 2-S receive FDA 510(k) clearance?

BioMonitor 2-AF, BioMonitor 2-S received FDA 510(k) clearance on 2017-03-31, under 510(k) number K170628.

Who is the listed applicant for BioMonitor 2-AF, BioMonitor 2-S?

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 2-AF, BioMonitor 2-S?

The FDA product code for BioMonitor 2-AF, BioMonitor 2-S is MXD.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Biotronik, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261074BIOMONITOR IV（471155）K250706Passeo-35 Xeo 周围血管扩张导管；Passeo-18 周围血管扩张导管；Passeo-14 周围血管扩张导管；Oscar 多功能导管系统；Pantera Pro 经皮腔内冠状动脉成形术导管；Pantera LEO 经皮腔内冠状动脉成形术（PTCA）导管K242969Pantera Pro; Pantera LEOK240787Selectra 3D 导线递送系统（443624-443629，451789-451791）；Selectra 切割工具（383119）；Selectra 配件套件（375518）K241711Oscar 外周多功能导管系统K230375BIOMONITOR IV

查看所有 23 个设备 →

相关器械（代码：MXD）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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 可植入式心脏监测器 (M302); LUX-Dx II+ 可植入式心脏监测器 (M312)Boston Scientific CorporationK240693LINQ II®植入式心脏监测器（ICM）Medtronic, Inc.

官方来源

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