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510(k) K042493

ENSITE SYSTEM, MODEL EE3000 by Endocardial Solutions, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2004
Date Received
September 14, 2004
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 Endocardial Solutions, Inc.

  • K033211 — ENSITE SYSTEM (October 30, 2003)
  • K030129 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (April 22, 2003)
  • K012926 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (September 28, 2001)
  • K001437 — ENSITE 3000 SYSTEM, MODEL EE3000 (June 7, 2000)
  • K993376 — ENSTYLET MODELS EC0010, EC0020 (January 5, 2000)
  • K992479 — ENSITE 3000 SYSTEM (December 2, 1999)
  • K983456 — ENSITE 3000 SYSTEM (April 21, 1999)

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  • 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)