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510(k) K911615

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 by Diagnostic Monitoring Software — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1992
Date Received
April 11, 1991
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 Diagnostic Monitoring Software

  • K133014 — DMS 300-2W HOLTER ECG RECORDER (May 19, 2014)
  • K062959 — DMS 300-2, 300-3 AND 300-4 (October 16, 2006)
  • K062088 — PREMIER 11 HOLTER (August 25, 2006)
  • K062007 — DMS 300-7 (August 16, 2006)

Other clearances for product code DQK

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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)