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510(k) K110693

PACEART OPTIMA SYSTEM SOFTWARE by Medtronic, Inc. — Product Code KRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2011
Date Received
March 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function, Indirect
Device Class
Class II
Regulation Number
870.3640
Review Panel
CV
Submission Type

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Other clearances for product code KRE

  • K072950 — CYGNUS 12 LEAD ECG MODULE (August 22, 2008)
  • K032926 — EKG SPEAKS (October 15, 2003)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • K895535 — PACEVIEW (March 19, 1990)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)
  • K833647 — PACEMAKER SYS ANALYZER #384 (December 16, 1983)
  • K832959 — PACEMAKER SYS. ANALYZER 378 (November 14, 1983)
  • K803286 — CARDIOMEMO (March 17, 1981)
  • K800696 — ELECTRONIC PACEMAKER WAVEFORM ANALYZER (August 14, 1980)