OMA · Class II · 21 CFR 882.1400

FDA Product Code OMA: Amplitude-integrated Electroencephalograph

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).

Leading manufacturers include Nihon Kohden America, Inc. and Eemagine Medical Imaging Solutions GmbH.

16
Total
16
Cleared
206d
Avg days
1979
Since

FDA 510(k) Cleared Amplitude-integrated Electroencephalograph Devices (Product Code OMA)

16 devices
1–16 of 16
Cleared Jan 30, 2020
Neo
K192889
Eemagine Medical Imaging Solutions GmbH
Neurology · 112d
Cleared Mar 16, 2012
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
K120485
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Jul 09, 2010
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
K092573
Nihon Kohden America, Inc.
Neurology · 323d

About Product Code OMA - Regulatory Context