K013389 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES. This device is classified as a Index-generating Electroencephalograph Software (Class II - Special Controls, product code OLW).
Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on January 10, 2002, 90 days after receiving the submission on October 12, 2001.
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 | K013389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2001 |
| Decision Date | January 10, 2002 |
| Days to Decision | 90 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. |