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510(k) K202876

Confirm Rx Insertable Cardiac Monitor by Abbott (St. Jude Medical) — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2020
Date Received
September 28, 2020
Clearance Type
Special
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)
  • K202888 — Confirm Rx Insertable Cardiac Monitor (November 23, 2020)
  • K200721 — Agilis HisPro Steerable Catheter With Electrodes (June 3, 2020)
  • K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (March 17, 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)
  • K202888 — Confirm Rx Insertable Cardiac Monitor (November 23, 2020)
  • K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (March 17, 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)