ECG Electrode (Various)

• • Terminated Z-1184-03 FDA Unclassified (pre-2012) ·initiated 30 Jul 2003

  Separation of the sensing element from the body of the electrode.

510(k) Number

K991105 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Thermogard & Thermogard Plus Abc

  Class II

  FDA 510(k) K972628 Active Cleared 27 Aug 1997

• Conmed Universal Plus

  Class II

  FDA 510(k) K934828 Active Cleared 7 Mar 1994

• Electrosurgical Dispersive Electrode

  Class II

  FDA 510(k) K983782 Active Cleared 25 Jan 1999

• Bend-A-Beam Hand Control Malleable ABC Handpiece

  Class II

  FDA 510(k) K961505 Active Cleared 18 Jul 1996

• Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult Diaphoretic Foam ECG Electrode Conm

  Class II

  FDA 510(k) K963787 Active Cleared 11 Mar 1997

• Aspen Surgical Systems Insufflation Tubing Set with Filter

  Class II

  FDA 510(k) K943954 Active Cleared 15 Nov 1994

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