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510(k) K133014

DMS 300-2W HOLTER ECG RECORDER by Diagnostic Monitoring Software — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2014
Date Received
September 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Diagnostic Monitoring Software

  • 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)
  • K911615 — HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 (January 8, 1992)

Other clearances for product code MWJ

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  • K233864 — ASSURE Wearable ECG (May 7, 2024)
  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K222017 — Biotres (July 28, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K211709 — Biotres (January 19, 2022)
  • K211651 — Eclipse PRO (November 22, 2021)
  • K173156 — Integrated CardioRespiratory System (June 8, 2018)
  • K161062 — NR Recorder (June 13, 2016)
  • K152626 — H3+ Holter Recorder (February 26, 2016)