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

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

510(k) Number

K001980 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

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. →

• What is the Aspect Medical Systems Pediatric Bis EEG Sensor used for?

  The Aspect Medical Systems Pediatric Bis EEG Sensor, Model 186-0110 is a cutaneous electrode device designed to measure brain activity in pediatric patients through the bispectral index (BIS) monitoring system.

• Is the Aspect Pediatric Bis EEG Sensor reusable or single-use?

  This device is supplied as a single-use product and is not intended for MRI environments. It requires proper handling to maintain sterility until use.

• What are the storage requirements for the Aspect Pediatric Bis EEG Sensor?

  The device should be stored according to the manufacturer's instructions to maintain its integrity and sterility until use.

• What is the regulatory classification of the Aspect Pediatric Bis EEG Sensor?

  The device is regulated under FDA 510(k) clearance with product code GXY and was classified for use in neurology.