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510(k) K062959

DMS 300-2, 300-3 AND 300-4 by Diagnostic Monitoring Software — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2006
Date Received
September 29, 2006
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

  • K133014 — DMS 300-2W HOLTER ECG RECORDER (May 19, 2014)
  • 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)

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  • 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)