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510(k) K930564

HOLTER FOR WINDOWS by North East Monitoring, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1995
Date Received
February 3, 1993
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 North East Monitoring, Inc.

  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)
  • K081861 — HOLTER LX ANALYSIS (December 4, 2008)
  • K070014 — AUTO DETECT FOR TELAHEART DR200/E-A (May 25, 2007)
  • K061293 — TELAHEART DIGITAL RECORDER (August 25, 2006)
  • K041901 — SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER (August 31, 2004)
  • K004007 — DR180+OXY (January 25, 2001)
  • K001288 — DR180-II (July 20, 2000)
  • K983576 — DR180-R/OXY (March 23, 1999)
  • K960925 — NORTHEAST MONITORING DR180 (July 31, 1996)

Other clearances for product code DQK

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