Home / 510(k) Clearances / K993617

510(k) K993617

DIGITRAKPLUS HOLTER RECORDER by Braemar Corp. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1999
Date Received
October 26, 1999
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 Braemar Corp.

  • K081444 — BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM (July 31, 2008)
  • K072008 — BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER (October 3, 2007)
  • K071733 — DL900 SERIES HOLTER RECORDER (July 24, 2007)
  • K071011 — MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER (April 27, 2007)
  • K042469 — BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER (October 6, 2004)
  • K030856 — ER800 SERIES ECG EVENT RECORDER (March 28, 2003)
  • K993618 — DXP1000 HOLTER RECORDER (November 24, 1999)
  • K981394 — BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 (September 28, 1998)
  • K945130 — BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER (April 12, 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)