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510(k) K201865

Biomonitor III, Biomonitor IIIm by Biotronik, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2020
Date Received
July 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Biotronik, Inc.

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  • K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitte (September 12, 2024)
  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • K230375 — BIOMONITOR IV (May 19, 2023)
  • K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter (February 16, 2023)
  • K221856 — BIOMONITOR IIIm, BIOMONITOR III (July 27, 2022)
  • K222037 — Selectra Lead Implantation System (July 19, 2022)
  • K214038 — Oscar Peripheral Multifunctional Catheter system (July 6, 2022)
  • K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter (September 2, 2021)

Other clearances for product code MXD

  • K253516 — Assert-IQ (DM5100) (December 18, 2025)
  • K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (September 17, 2025)
  • K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monit (September 12, 2025)
  • K240693 — LINQ II™ Insertable Cardiac Monitor (ICM) (March 28, 2024)
  • K233562 — LINQ II Insertable Cardiac Monitor (December 6, 2023)
  • K233320 — LINQ II™ Insertable Cardiac Monitor (LNQ22) (October 31, 2023)
  • K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) (August 19, 2023)
  • K230375 — BIOMONITOR IV (May 19, 2023)
  • K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (April 26, 2023)
  • K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, Accu (April 5, 2023)