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 Olympic Medical Corp., 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
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149
Olympic Medical Corp.
Neurology · 34d
Cleared Mar 23, 1999
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
K983229
Olympic Medical Corp.
Neurology · 189d

About Product Code OMA - Regulatory Context