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510(k) K032225

EP-WORKMATE WITH RPM SYSTEM by Ep Medsystems — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2003
Date Received
July 21, 2003
Clearance Type
Special
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 Ep Medsystems

  • K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (October 16, 2009)
  • K073709 — MODIFICATION TO VIEWMATE SYSTEM (March 11, 2008)
  • K071028 — VIEWMATE SYSTEM (May 1, 2007)
  • K070706 — EP-WORKMATE (April 11, 2007)
  • K063277 — MAPMATE (November 30, 2006)
  • K063113 — EP-WORKMATE (October 27, 2006)
  • K041442 — EP-4 CLINICAL STIMUTATOR (September 14, 2004)
  • K033963 — EP DEFLECTABLE CATHETERS (April 15, 2004)
  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K031066 — VIEWMATE ULTRASOUND IMAGING SYSTEM (October 17, 2003)

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  • 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)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)