K152301 is an FDA 510(k) clearance for the Background Pattern Classification [BPc(TM)]. This device is classified as a Amplitude-integrated Electroencephalograph (Class II - Special Controls, product code OMA).
Submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on June 3, 2016, 294 days after receiving the submission on August 14, 2015.
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 | K152301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2015 |
| Decision Date | June 03, 2016 |
| Days to Decision | 294 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). |