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510(k) K780717

EXTERNAL TEST PULSE GENERATOR by Vitatron Medical BV — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1978
Date Received
April 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function
Device Class
Class II
Regulation Number
870.3630
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)
  • K844485 — CERYX6, 611, CERYX 3 311 & CERYX 1 111 (April 19, 1985)
  • K844483 — TP 1 (April 19, 1985)
  • K840668 — ELECTRODE PACEMAKER, PERM & TEMP (September 24, 1984)
  • K831860 — GENERATOR, PULSE, PACEMAKER #532 (October 27, 1983)
  • K831859 — PACEMAKER PROGRAMMER #2032 (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)

Other clearances for product code DTC

  • K170815 — PSA Cable (July 6, 2017)
  • K083674 — PK-141 PATIENT CABLE (April 1, 2009)
  • K011729 — SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 (August 30, 2001)
  • K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER (October 10, 2000)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K903966 — EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (June 19, 1991)
  • K910595 — MODEL 5311B A-V PACING SYSTEM ANALYZER (May 7, 1991)
  • K910223 — CPI MODEL 2215/SEAMED MODEL 3400 (March 19, 1991)
  • K901332 — PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (May 9, 1990)
  • K896632 — MEDTRONIC MODEL 5401B TEST CABLE (December 13, 1989)