Cleared Traditional

Ceribell Pocket EEG Device

K170363 · Ceribell, Inc. · Neurology

May 2017

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K170363 is an FDA 510(k) clearance for the Ceribell Pocket EEG Device, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Ceribell, Inc. (Mountainview, US). The FDA issued a Cleared decision on May 8, 2017, 91 days after receiving the submission on February 6, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K170363 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2017
Decision Date	May 08, 2017
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- Montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes