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510(k) K895535

PACEVIEW by Micromedical — Product Code KRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1990
Date Received
September 13, 1989
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 Micromedical

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  • K974351 — BIOLOG 3000 ELECTROCARDIOGRAPH (April 1, 1998)
  • K970305 — PRINTER INTERFACE (August 15, 1997)
  • K955891 — CARDIOVIEW TRANSTELEPHONIC SOFTWARE (October 8, 1996)
  • K895534 — BIOLOG (March 19, 1990)

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  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • 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)