Cleared Traditional

SPARK Scan

K231457 · Spark Neuro, Inc. · Neurology
Aug 2023
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K231457 is an FDA 510(k) clearance for the SPARK Scan, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Spark Neuro, Inc. (New York, US). The FDA issued a Cleared decision on August 18, 2023, 91 days after receiving the submission on May 19, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K231457 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2023
Decision Date August 18, 2023
Days to Decision 91 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWQ — Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations