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510(k) K831697

TELECTRONICS MODEL 2401 by Seamed Corp. — Product Code DTC

K831697 is an FDA 510(k) premarket notification submitted by Seamed Corp. for the device "TELECTRONICS MODEL 2401". The FDA issued a decision of Substantially Equivalent on September 4, 1984. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Seamed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1984
Date Received
May 25, 1983
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.

  • 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)
  • K852746 — EXTERNAL PACEMAKER TELECTRONICS TE200 (September 12, 1985)

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)

FDA data resources