Home / 510(k) Clearances / K211557

510(k) K211557

EndoPATx by Itamar Medical , Ltd. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2022
Date Received
May 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Itamar Medical , Ltd.

  • K250460 — WatchPAT400 (WP400) (September 5, 2025)
  • K223675 — WatchPAT ONE (WP1) (January 6, 2023)
  • K222331 — WatchPAT300 (WP300) (September 14, 2022)
  • K203839 — WatchPAT200U (WP200U) (March 21, 2022)
  • K183559 — WatchPAT ONE (June 5, 2019)
  • K180775 — Watch-PAT300 (August 17, 2018)
  • K161579 — Watch-PAT200U (February 24, 2017)
  • K153070 — Watch-PAT200U (July 26, 2016)
  • K133859 — WATCH-PAT200U (WP200U) (May 30, 2014)
  • K102567 — WATCH-PAT 200S-3 (WP200S-3) (June 2, 2011)

Other clearances for product code DQK

  • K253861 — ACORYS MAPPING SYSTEM (April 13, 2026)
  • K253473 — Synchrony (April 1, 2026)
  • K253186 — HemoSphere Nano Monitor (HSNANO1) (February 24, 2026)
  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 (February 17, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)