510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000068Substantially Equivalent

Compumedics E-Series EEG System

Compumedics Neuro Science Pty, Ltd., Findley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000068 is the FDA 510(k) clearance record for COMPUMEDICS E-SERIES EEG SYSTEM, a class II device, cleared for Compumedics Neuro Science Pty , Ltd. on under FDA product code OLT (Non-Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLT reads: "Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user". FDA records list one 510(k) clearance for Compumedics Neuro Science Pty , Ltd. As of , FDA records show one recall naming K000068.

Clearance record

Decision date
Received
(63 days to decision)
Product code
OLT Non-Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Compumedics Neuro Science Pty , Ltd. 6470 Riverview Ter., Findley MN
510(k) summary
Summary
Third party review
No

Clearances, product code OLT

Trailing 12 months
4 clearances under product code OLT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20261
October 20260