Cleared Traditional

DeltaScan Monitor

K222680 · Prolira B.V. · Neurology
Feb 2023
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K222680 is an FDA 510(k) clearance for the DeltaScan Monitor, a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (Class II — Special Controls, product code NCG), submitted by Prolira B.V. (Utrecht, NL). The FDA issued a Cleared decision on February 2, 2023, 149 days after receiving the submission on September 6, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1440.

Submission Details

510(k) Number K222680 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2022
Decision Date February 02, 2023
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NCG — Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1440
Definition Uses A Patient's Electroencephalograph (eeg) To Provide An Interpretation Of The Patient's Neuropsychiatric Condition. It Is Also Used Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis."