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510(k) K193310

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) by Abbott (St. Jude Medical) — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2020
Date Received
November 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Abbott (St. Jude Medical)

  • K212206 — Jot Dx Insertable Cardiac Monitor (August 13, 2021)
  • K202876 — Confirm Rx Insertable Cardiac Monitor (December 1, 2020)
  • K202888 — Confirm Rx Insertable Cardiac Monitor (November 23, 2020)
  • K200721 — Agilis HisPro Steerable Catheter With Electrodes (June 3, 2020)
  • K190295 — Confirm Rx Insertable Cardiac Monitor (April 10, 2019)

Other clearances for product code MXC

  • K230286 — Assert-IQ™ Insertable Cardiac Monitor (May 17, 2023)
  • K212206 — Jot Dx Insertable Cardiac Monitor (August 13, 2021)
  • K202876 — Confirm Rx Insertable Cardiac Monitor (December 1, 2020)
  • K202888 — Confirm Rx Insertable Cardiac Monitor (November 23, 2020)
  • K192593 — Confirm Rx Insertable Cardiac Monitor (October 18, 2019)
  • K190295 — Confirm Rx Insertable Cardiac Monitor (April 10, 2019)
  • K182981 — Confirm Rx Insertable Cardiac Monitor (March 29, 2019)
  • K173232 — myMerlin(TM) Mobile Application Model APP1001 (November 2, 2017)
  • K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System (September 29, 2017)
  • K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (May 28, 2014)