FDA 510(k)

BIOMONITOR IIIm, BIOMONITOR III

N.º K: K221856 · 2022-07-27

Fecha de decisión2022-07-27

Código de productoMXD

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Biotronik, Inc. como solicitante

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) Catheter K242969Pantera Pro; Pantera LEO K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)K241711Oscar Peripheral Multifunctional Catheter system K230375BIOMONITOR IV

Ver todos los 23 dispositivos →

Dispositivos relacionados (Código: MXD)

K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICAL K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.

Fuente oficial

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