Seamed Model 4000

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K854648 ↗

FDA Product Code

DTE

Device Class

Class II

Regulation

21 CFR Part 870.3600

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sea Med Ddd Pacing System Analyzer

  Class II

  FDA 510(k) K851900 Active Cleared 19 Jul 1985

• Telectronics Model 2401

  Class II

  FDA 510(k) K831697 Active Cleared 4 Sep 1984

• Seamed 4000

  Class II

  FDA 510(k) K843777 Active Cleared 1 Feb 1985

• Seamed Model 3200

  Class II

  FDA 510(k) K872551 Active Cleared 31 Jul 1987

• Seamed Model 3000

  Class II

  FDA 510(k) K860462 Active Cleared 19 Aug 1986

• Sea Med Model 880

  Class II

  FDA 510(k) K823048 Active Cleared 15 Dec 1982

See all devices from Seamed Corp. →