DISPOSABLE ECG MONITORING ELECTRODES - 4539

• • Terminated Z-1431-2010 FDA Unclassified (pre-2012) ·initiated 11 Mar 2010

  In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.

510(k) Number

K990113 ↗

FDA Product Code

DRX

Models / Variants

4500

4530

4533

4539

4540

4560

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Disposable ECG Monitoring Electrodes, Models 4060, 4610

  Class II

  FDA 510(k) K990112 Active Cleared 6 Dec 1999

• Paradigm Quick-Set Infusion Set

  Class II

  FDA 510(k) K011071 Active Cleared 7 Jun 2001

• Disposable ECG Monitoring Electrodes, Models, 4420, 4440

  Class II

  FDA 510(k) K990115 Active Cleared 6 Dec 1999

• Disposable ECG Monitoring Electrodes, Models 4520, 4535, 4570

  Class II

  FDA 510(k) K990111 Active Cleared 6 Dec 1999

• 4l Drainage Bag, 4l Bag for Peritoneal Dialysis, 4l Urinary Drainage Bag

  Class II

  FDA 510(k) K973364 Active Cleared 17 Mar 1998

• Disposable ECG Monitoring Electrodes, Model 4110, 4140

  Class II

  FDA 510(k) K990110 Active Cleared 6 Dec 1999

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