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510(k) K895535

PACEVIEW by Micromedical — Product Code KRE

K895535 is an FDA 510(k) premarket notification submitted by Micromedical for the device "PACEVIEW". The FDA issued a decision of Substantially Equivalent on March 19, 1990. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Micromedical has at least 6 other 510(k) clearances on record.

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

  • K974352 — CARDIOVIEW 3000 SOFTWARE (September 8, 1998)
  • K974220 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (August 25, 1998)
  • 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)

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)
  • 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)

FDA data resources