Nihon Kohden QP-160AK EEG Trend Program
FDA 510(k) K163644 · Nihon Kohden Corporation
510(k) numberK163644
Submission
- Device name
- Nihon Kohden QP-160AK EEG Trend Program
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- December 23, 2016
- Decision date
- May 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMA – Amplitude-Integrated Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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).
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Questions and answers
When was Nihon Kohden QP-160AK EEG Trend Program cleared by the FDA?
Nihon Kohden QP-160AK EEG Trend Program (K163644) received a 510(k) decision of Substantially Equivalent on May 19, 2017, 147 days after the submission was received.
What is the product code of K163644?
The FDA product code is OMA – Amplitude-Integrated Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.