510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843808Substantially Equivalent

Dual Chennel Brain Activity Monitor

Datex Division Instrumentarium Corp., Helsinki 10 Finland / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843808 is the FDA 510(k) clearance record for DUAL CHENNEL BRAIN ACTIVITY MONITOR, a class II device, cleared for Datex Division Instrumentarium Corp. 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 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K843808.

Clearance record

Decision date
Received
(42 days to decision)
Product code
OLT Non-Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Datex Division Instrumentarium Corp. P.O. Box 357, Helsinki 10 Finland
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