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510(k) K122272

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
July 30, 2012
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)
  • K063042 — CARDIOMEM CM 3000-12BT (May 30, 2007)
  • K070280 — CARDIODAY, VERSION 2.0 (February 23, 2007)
  • K051686 — CARDIOMEM CM 3000-12 (July 14, 2005)
  • 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)