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510(k) K860462

SEAMED MODEL 3000 by Seamed Corp. — Product Code DTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
February 6, 1986
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 Seamed Corp.

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  • K912507 — CPI MODEL 2215 & SEAMED MODEL 3400 (September 3, 1991)
  • K910223 — CPI MODEL 2215/SEAMED MODEL 3400 (March 19, 1991)
  • K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY (November 9, 1988)
  • K872551 — SEAMED MODEL 3200 (July 31, 1987)
  • K863903 — SEA MED MODEL 6000 (December 10, 1986)
  • K854648 — SEAMED MODEL 4000 (January 16, 1986)
  • K852746 — EXTERNAL PACEMAKER TELECTRONICS TE200 (September 12, 1985)
  • K851900 — SEA MED DDD PACING SYSTEM ANALYZER (July 19, 1985)

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  • 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)