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510(k) K142424

DR300 HOLTER MONITOR by North East Monitoring, Inc. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2014
Date Received
August 29, 2014
Clearance Type
Traditional
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 North East Monitoring, Inc.

  • 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)
  • K930564 — HOLTER FOR WINDOWS (April 19, 1995)

Other clearances for product code MWJ

  • K231424 — HeartBeam AIMIGo(TM) System (December 13, 2024)
  • 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)