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510(k) K130516

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2013
Date Received
February 27, 2013
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

  • K162023 — CardioDay V2.5 (March 24, 2017)
  • 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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