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510(k) K070280

CARDIODAY, VERSION 2.0 by Getemed Medizin- Und Informationstechnik AG — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2007
Date Received
January 29, 2007
Clearance Type
Special
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

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

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  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
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