Bis Engine

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K002837 ↗

FDA Product Code

OLW

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• A-1050 EEG Monitor

  Class II

  FDA 510(k) K952347 Active Cleared 16 Jan 1996

• Zipprep Electrode

  Class II

  FDA 510(k) K940802 Active Cleared 22 Jun 1994

• 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

See all devices from Aspect Medical Systems, Inc. →