Cleared Traditional

K143506 - BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES) (FDA 510(k) Clearance)

Also includes:
BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES BIS QUATRO SENSOR BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES) BIS EXTEND SENSOR BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES) BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)
K143506 · Covidien · Neurology device
Apr 2015
Decision
127d
Days
Class 2
Risk

K143506 is an FDA 510(k) clearance for the BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on April 16, 2015, 127 days after receiving the submission on December 10, 2014.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K143506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2014
Decision Date April 16, 2015
Days to Decision 127 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.1320