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510(k) K884522

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER by Teletronics, Inc. — Product Code KRG

K884522 is an FDA 510(k) premarket notification submitted by Teletronics, Inc. for the device "MODEL 5650 OPTIMATE PERSONAL PROGRAMMER". The FDA issued a decision of Substantially Equivalent on August 25, 1989. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1989
Date Received
October 27, 1988
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 for product code KRG

  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • 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)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)

FDA data resources