Multiple

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K863387 ↗

FDA Product Code

DXK

Device Class

Class II

Regulation

21 CFR Part 870.2330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioguard Stress Test Monitor 4002

  Class II

  FDA 510(k) K850043 Active Cleared 8 Feb 1985

• Holter PacerCorder

  Class II

  FDA 510(k) K950020 Active Cleared 17 Aug 1995

• Model 9300 Electrocardiovalidator

  Class I

  FDA 510(k) K801830 Active Cleared 27 Aug 1980

• Model 463 Electrocardiorecorder Recorder

  Class II

  FDA 510(k) K884330 Active Cleared 5 Jan 1989

• Holter Digicorder with Pacer Option (Model 483)

  Class II

  FDA 510(k) K963174 Active Cleared 13 Mar 1997

• Treadmill E-17

  Class I

  FDA 510(k) K850044 Active Cleared 4 Apr 1985

See all devices from Del Mar Avionics →