K163644 is an FDA 510(k) clearance for the Nihon Kohden QP-160AK EEG Trend Program. This device is classified as a Amplitude-integrated Electroencephalograph (Class II - Special Controls, product code OMA).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on May 19, 2017, 147 days after receiving the submission on December 23, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. 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)..
| 510(k) Number | K163644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2016 |
| Decision Date | May 19, 2017 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OMA - Amplitude-integrated Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | 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). |