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510(k) K912507

CPI MODEL 2215 & SEAMED MODEL 3400 by Seamed Corp. — Product Code DTE

K912507 is an FDA 510(k) premarket notification submitted by Seamed Corp. for the device "CPI MODEL 2215 & SEAMED MODEL 3400". The FDA issued a decision of Substantially Equivalent on September 3, 1991. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Seamed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1991
Date Received
June 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
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)
  • 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)
  • K851900 — SEA MED DDD PACING SYSTEM ANALYZER (July 19, 1985)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)

FDA data resources