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510(k) K230375

BIOMONITOR IV by Biotronik, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
February 13, 2023
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

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Other clearances for product code MXD

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  • 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)
  • 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)
  • K221962 — LINQ II Insertable Cardiac Monitor (August 25, 2022)