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510(k) K083674

PK-141 PATIENT CABLE by Biotronik, Inc. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2009
Date Received
December 11, 2008
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

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Other clearances for product code DTC

  • K170815 — PSA Cable (July 6, 2017)
  • 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)
  • K884331 — MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER (January 10, 1989)