Home / 510(k) Clearances / K171514

510(k) K171514

BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set by Biotronik, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2017
Date Received
May 24, 2017
Clearance Type
Special
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

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Other clearances for product code MXD

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  • 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)
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