K061907 is an FDA 510(k) clearance for the MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES. This device is classified as a Index-generating Electroencephalograph Software (Class II - Special Controls, product code OLW).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on March 27, 2008, 631 days after receiving the submission on July 5, 2006.
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 | K061907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2006 |
| Decision Date | March 27, 2008 |
| Days to Decision | 631 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. |