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510(k) K800696

ELECTRONIC PACEMAKER WAVEFORM ANALYZER by Instromedix, Inc. — Product Code KRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1980
Date Received
March 28, 1980
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

Other clearances by Instromedix, Inc.

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  • K964036 — CARDIOMAGIC 2000 SOFTWARE (July 18, 1997)
  • K955060 — ACCELERATED TRANSMISSION PROTOCOL (April 8, 1996)
  • K951096 — LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER (January 16, 1996)
  • K945476 — HEARTHWATCH III(TM) (November 9, 1995)
  • K950003 — CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (October 31, 1995)
  • K944362 — HEARTCARD CARDIAC EVENT MONITOR (September 7, 1995)
  • K943931 — CARRYALL ENHANCEMENTS (April 4, 1995)
  • K935586 — PRINCE (November 8, 1994)

Other clearances for product code KRE

  • K110693 — PACEART OPTIMA SYSTEM SOFTWARE (June 8, 2011)
  • 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)