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510(k) K063042

CARDIOMEM CM 3000-12BT by Getemed Medizin- Und Informationstechnik AG — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2007
Date Received
October 3, 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 Getemed Medizin- Und Informationstechnik AG

  • K162023 — CardioDay V2.5 (March 24, 2017)
  • K130516 — CARDIODAY (August 23, 2013)
  • K130785 — SEER 1000 (July 26, 2013)
  • K122272 — CARDIOMEM (March 28, 2013)
  • K070280 — CARDIODAY, VERSION 2.0 (February 23, 2007)
  • K051686 — CARDIOMEM CM 3000-12 (July 14, 2005)
  • K051471 — CARDIODAY (June 29, 2005)

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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)