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510(k) K860249

THE HOLTER REPORTER (TM) by Applied Cardiac Systems — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1986
Date Received
January 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Applied Cardiac Systems

  • K103706 — THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR (August 24, 2011)
  • K042413 — ACS MODEL NCP-2 (December 9, 2004)
  • K833823 — HOLTER PERFORMER FEATHER WEIGHT/CASS (December 1, 1983)
  • K813602 — HOLTER PERFORMER (January 29, 1982)

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  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)