Mac-Lab/Cardiolab Ep/Combolab

• • Terminated Z-0783-03 FDA Unclassified (pre-2012) ·initiated 14 Apr 2003 ·on shared 510(k) K021366

  There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021366 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Case 8000 Exercise Testing System

  Not classified

  FDA 510(k) K991014 Active Cleared 20 Oct 1999

• Solar 7/8000

  Class II

  FDA 510(k) K993757 Active Cleared 23 Mar 2000

• Bis/EEG Module

  Class II

  FDA 510(k) K012466 Active Cleared 1 Oct 2001

• Solar 8000M System Open recall

  Class II

  FDA 510(k) K012467 Active Cleared 11 Feb 2002

• Dash 3000 Patient Monitor Open recall

  Class II

  FDA 510(k) K992929 Active Cleared 26 Nov 1999

• Dash 3000/4000 Patient Monitor Open recall

  Class II

  FDA 510(k) K001359 Active Cleared 18 Jul 2000

See all devices from General Electric Medical Systems Information Techn →