Home / 510(k) Clearances / K051686

510(k) K051686

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2005
Date Received
June 23, 2005
Clearance Type
Abbreviated
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)
  • K063042 — CARDIOMEM CM 3000-12BT (May 30, 2007)
  • K070280 — CARDIODAY, VERSION 2.0 (February 23, 2007)
  • K051471 — CARDIODAY (June 29, 2005)

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)