Ndi-Ike Emg

FDA 510(k) K801670 · Neurodiagnostics, Inc.

Substantially Equivalent

510(k) numberK801670

Submission

Device name
Ndi-Ike Emg
Applicant
Neurodiagnostics, Inc.
Mchenry, IL, US
Received
July 22, 1980
Decision date
August 4, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWK – Conditioner, Signal, Physiological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1845
Specialty
Neurology

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K991045Mini-Logger Series 2000GWK · Traditional Mini-Mitter Co., Inc.09/21/1999SE
K905594Neurofile Data Storage/Accesories to the EEG-4300GWK · Traditional Nihon Kohden America, Inc.06/28/1991SE
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K896164ASC-954 Integrator AmplifierGWK · Traditional Astro-Med, Inc.01/22/1990SE
K882599Nicolet Brainlab SystemGWK · Traditional Nicolet Instrument Corp.10/19/1988SE
K872290Bio-Logic BankerGWK · Traditional Bio-Logic Systems Corp.10/06/1987SE
K870381DD-VCR-64GWK · Traditional Grass-Telefactor Product Group03/25/1987SE

More from Grass-Telefactor Product Group

510(k)DeviceDecision
K843253Emg/Ncv & Evoked Response, Design W/GWF · Traditional 11/20/1984SE
K830191Neuro Diagnostics Model FCRGWK · Traditional 02/18/1983SE
K801671ESG-1 (Evoked Response Stimulus Gener)GWE · Traditional 08/04/1980SE

Questions and answers

When was Ndi-Ike Emg cleared by the FDA?

Ndi-Ike Emg (K801670) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 13 days after the submission was received.

What is the product code of K801670?

The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.