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510(k) K852746

EXTERNAL PACEMAKER TELECTRONICS TE200 by Seamed Corp. — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1985
Date Received
June 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device Class
Class II
Regulation Number
870.1750
Review Panel
CV
Submission Type

Other clearances by Seamed Corp.

  • K923398 — CPI MODEL 2215 (August 14, 1992)
  • K915364 — CHRONOCOR VI MODEL 5012 (February 7, 1992)
  • 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)
  • K860462 — SEAMED MODEL 3000 (August 19, 1986)
  • K854648 — SEAMED MODEL 4000 (January 16, 1986)
  • K851900 — SEA MED DDD PACING SYSTEM ANALYZER (July 19, 1985)

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  • K935590 — EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (May 5, 1994)