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510(k) K860546

DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 by Pacesetter Systems — Product Code KRG

K860546 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Pacesetter Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
February 13, 1986
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 Pacesetter Systems

  • K910924 — ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE (August 28, 1991)
  • K902147 — ENDOCARDIAL SCREW-IN LEAD MODEL 1028T (July 17, 1990)
  • K900512 — SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS (June 25, 1990)
  • K900550 — FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T (April 20, 1990)
  • K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (December 20, 1989)
  • K891905 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (June 5, 1989)
  • K885267 — VS-1 MODEL NUMBER 251K PULSE GENERATOR (March 28, 1989)
  • K890547 — SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS (March 22, 1989)
  • K884733 — AFP MODEL 262T PULSE GENERATOR (February 10, 1989)
  • K883087 — PROLOG MP 658M PULSE GENERATOR (September 14, 1988)

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)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)

FDA data resources