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

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963787 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• ECG Electrode (Various)

  Class II

  FDA 510(k) K991105 Active Cleared 26 Nov 1999

• 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

• Aspen Surgical Systems Insufflation Tubing Set with Filter

  Class II

  FDA 510(k) K943954 Active Cleared 15 Nov 1994

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