510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192889Substantially Equivalent

Neo

Eemagine Medical Imaging Solutions GmbH, Berlin, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192889 is the FDA 510(k) clearance record for Neo, a class II device, cleared for Eemagine Medical Imaging Solutions GmbH on under FDA product code OMA (Amplitude-Integrated Electroencephalograph). FDA's definition for product code OMA reads: "Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner)". FDA records list 8 510(k) clearances for Eemagine Medical Imaging Solutions GmbH, from to . As of , FDA records show no recalls naming K192889.

Clearance record

Decision date
Received
(112 days to decision)
Product code
OMA Amplitude-Integrated Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Eemagine Medical Imaging Solutions GmbH Gubener St. 47, Berlin, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMA

Trailing 12 months

FDA records hold no clearances under product code OMA in the trailing twelve months.

FDA records show no clearances under product code OMA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260