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510(k) K800376

EPR-200 PROGRAMMER MODEL 010 by Biotronik Sales, Inc. — Product Code KRG

K800376 is an FDA 510(k) premarket notification submitted by Biotronik Sales, Inc. for the device "EPR-200 PROGRAMMER MODEL 010". The FDA issued a decision of Substantially Equivalent on April 21, 1980. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Biotronik Sales, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1980
Date Received
February 21, 1980
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 Biotronik Sales, Inc.

  • K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (February 18, 1988)
  • K853194 — ERA-20 (March 11, 1987)
  • K860036 — EDP-20 PACEMAKER (January 12, 1987)
  • K863878 — TRIOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863879 — NEOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863480 — BIOTRONIK PERMANENT PACEMAKER ELECTRODE (September 23, 1986)
  • K860921 — NEOS VS-1, PULSE GENERATOR (August 8, 1986)
  • K860922 — MIKROS, MIKROS VS-1, PULSE GENERATOR (August 4, 1986)
  • K853567 — DJP UNIPOLAR (May 7, 1986)
  • K853566 — DJ UNIPOLAR (May 7, 1986)

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)

FDA data resources