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510(k) K162023

CardioDay V2.5 by Getemed Medizin- Und Informationstechnik AG — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2017
Date Received
July 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Getemed Medizin- Und Informationstechnik AG

  • 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)
  • K051686 — CARDIOMEM CM 3000-12 (July 14, 2005)
  • K051471 — CARDIODAY (June 29, 2005)

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  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)