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510(k) K844485

CERYX6, 611, CERYX 3 311 & CERYX 1 111 by Vitatron Medical BV — Product Code KRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
November 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type

Other clearances by Vitatron Medical BV

  • K854790 — CERYX PACEMAKER MODELS 114, 314 & 614 (August 28, 1986)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)
  • K844483 — TP 1 (April 19, 1985)
  • K840668 — ELECTRODE PACEMAKER, PERM & TEMP (September 24, 1984)
  • K831859 — PACEMAKER PROGRAMMER #2032 (October 27, 1983)
  • K831860 — GENERATOR, PULSE, PACEMAKER #532 (October 27, 1983)
  • K810928 — ENDOCARDIAL ELECTRODE (July 2, 1981)
  • K791920 — CARDIAC PACEMAKER P4000 SER. & P1000 (November 29, 1979)
  • K791921 — CARDIAC PACEMAKER C4000, C1000 SER. (October 26, 1979)
  • K791380 — VA 1000 (September 19, 1979)

Other clearances for product code KRG

  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K884522 — MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (August 25, 1989)
  • K880738 — MODEL 2331T PATIENT PROGRAMMER (November 17, 1988)
  • K882429 — MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (July 22, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K871986 — MODEL 5600B PROGRAMMER, PACEMAKER (June 24, 1987)
  • K863046 — ULTRA SOFTWARE MODULE: MODEL 2016 (December 5, 1986)
  • K863045 — PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (September 29, 1986)
  • K860584 — SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (June 6, 1986)
  • K860546 — DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (April 23, 1986)