K150298 is an FDA 510(k) clearance for the Entropy Module, E-ENTROPY-01. This device is classified as a Index-generating Electroencephalograph Software (Class II - Special Controls, product code OLW).
Submitted by Ge Healthcare Filand OY (Helsinki, FI). The FDA issued a Cleared decision on November 12, 2015, 279 days after receiving the submission on February 6, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User..
| 510(k) Number | K150298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2015 |
| Decision Date | November 12, 2015 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLW — Index-generating Electroencephalograph Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User. |