Cleared Traditional

Natus BrainWatch System

K242930 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology
Nov 2024
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K242930 is an FDA 510(k) clearance for the Natus BrainWatch System, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on November 19, 2024, 56 days after receiving the submission on September 24, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K242930 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2024
Decision Date November 19, 2024
Days to Decision 56 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