510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041263Substantially Equivalent

Neuroguide Analysis System

Applied Neuroscience, Inc., St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041263 is the FDA 510(k) clearance record for NEUROGUIDE ANALYSIS SYSTEM, a class II device, cleared for Applied Neuroscience, Inc. on under FDA product code OLU (Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLU reads: "Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user". FDA records list one 510(k) clearance for Applied Neuroscience, Inc. As of , FDA records show no recalls naming K041263.

Clearance record

Decision date
Received
(84 days to decision)
Product code
OLU Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Applied Neuroscience, Inc. 228 176th Ter. Dr., St. Petersburg FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLU

Trailing 12 months
1 clearance under product code OLU in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260