Neuroscience MAP-10 EEG

FDA 510(k) K850430 · Neuroscience, Inc.

Substantially Equivalent

510(k) numberK850430

Submission

Device name
Neuroscience MAP-10 EEG
Applicant
Neuroscience, Inc.
Los Altos, CA, US
Received
February 4, 1985
Decision date
July 17, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWS – Analyzer, Spectrum, Electroencephalogram Signal
Device class
Class I (low risk)
Regulation
21 CFR 882.1420
Specialty
Neurology

Other 510(k)s with product code GWS

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K974718Persyst PrismGWS · Traditional Persyst Development Corp.03/09/1998SE
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K912938RhythmGWS · Traditional Stellate Systems07/30/1991SE
K894629Nicolet Beam II SystemGWS · Traditional Nicolet Instrument Corp.03/09/1990SE
K871931Istat SoftwareGWS · Traditional Neuroscience, Inc.10/13/1987SE
K871480STD-228 Spectral Trend DisplayGWS · Traditional Grass-Telefactor Product Group05/01/1987SE
K854662OEE_7102 Eeg/Trend MonitorGWS · Traditional Nihon Kohden America, Inc.08/20/1986SE
K860829CNS 4/8 and CT 48.1 SoftwareGWS · Traditional Cns, Inc.05/29/1986SE
K854160CNS-16 & LTM 1.0 SoftwareGWS · Traditional Cns, Inc.01/10/1986SE
K844481Neurolab IIGWS · Traditional Teca, Inc.05/20/1985SE

More from Teca, Inc.

510(k)DeviceDecision
K871931Istat SoftwareGWS · Traditional 10/13/1987SE
K870263Neuromapper 1620GWQ · Traditional 04/10/1987SE
K855232Somatosensory Evoked Potential StimulatorGWF · Traditional 07/03/1986SE

Questions and answers

When was Neuroscience MAP-10 EEG cleared by the FDA?

Neuroscience MAP-10 EEG (K850430) received a 510(k) decision of Substantially Equivalent on July 17, 1985, 163 days after the submission was received.

What is the product code of K850430?

The FDA product code is GWS – Analyzer, Spectrum, Electroencephalogram Signal, a Class I (low risk) device regulated under 21 CFR 882.1420.