Zipprep Electrode

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

510(k) Number

K940802 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• A-1050 EEG Monitor

  Class II

  FDA 510(k) K952347 Active Cleared 16 Jan 1996

• Bis Srs (Semi-Resuable Sensor)

  Class I

  FDA 510(k) K050313 Active Cleared 24 Feb 2005

• Aspect Medical Systems Zipprep EEG Sensor

  Class II

  FDA 510(k) K961821 Active Cleared 4 Oct 1996

• Bis Click Sensor/Cable

  Class II

  FDA 510(k) K091854 Active Cleared 2 Jul 2009

• A-2000 EEG Monitor with Bis

  Class II

  FDA 510(k) K974496 Active Cleared 6 Feb 1998

• Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110

  Class II

  FDA 510(k) K001980 Active Cleared 27 Sep 2000

See all devices from Aspect Medical Systems, Inc. →

• What is the intended use of the Zipprep Electrode?

  The Zipprep Electrode is designed to be applied directly to a patient's forehead for the purpose of recording electro-physiological signals.

• Is the Zipprep Electrode intended for reuse?

  No, the Zipprep Electrode is a disposable device intended for single patient use only. It should be discarded after the procedure to ensure hygiene and signal integrity.

• How is the Zipprep Electrode supplied?

  The device is supplied as a pre-gelled, disposable sensor, which simplifies the application process by eliminating the need for manual gel application during clinical use.

• What is the regulatory status of this device?

  The Zipprep Electrode has received FDA 510(k) clearance under K940802, confirming it has been found substantially equivalent to predicate devices for its intended use.