Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box
FDA 510(k) K113117 · Nihon Kohden America, Inc.
510(k) numberK113117
Submission
- Device name
- Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box
- Applicant
- Nihon Kohden America, Inc.
Foothill, CA, US - Received
- October 21, 2011
- Decision date
- March 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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Questions and answers
When was Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box cleared by the FDA?
Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction Box (K113117) received a 510(k) decision of Substantially Equivalent on March 22, 2012, 153 days after the submission was received.
What is the product code of K113117?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.