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510(k) K871986

MODEL 5600B PROGRAMMER, PACEMAKER by Telectronics, Inc. — Product Code KRG

K871986 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "MODEL 5600B PROGRAMMER, PACEMAKER". The FDA issued a decision of Substantially Equivalent on June 24, 1987. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Telectronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1987
Date Received
May 22, 1987
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 Telectronics, Inc.

  • K890895 — IMPLANTABLE ADAPTOR 033-380 (March 6, 1990)
  • K891231 — OPTIMA MPT AND SPT PACEMAKERS (September 12, 1989)
  • K890350 — VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (February 2, 1989)
  • K884411 — OPTIMA MPT AND SPT PACEMAKERS (January 26, 1989)
  • K884278 — IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (December 15, 1988)
  • K881837 — OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (July 18, 1988)
  • K874664 — IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (May 31, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K872766 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (November 4, 1987)
  • K865098 — SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 (August 18, 1987)

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)
  • 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