K161027 is an FDA 510(k) clearance for the Cadwell AmpliScan. This device is classified as a Amplitude-integrated Electroencephalograph (Class II - Special Controls, product code OMA).
Submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on November 8, 2016, 210 days after receiving the submission on April 12, 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 | K161027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2016 |
| Decision Date | November 08, 2016 |
| Days to Decision | 210 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). |