K051883 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.. This device is classified as a Non-normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLT).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on August 5, 2005, 24 days after receiving the submission on July 12, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User..
| 510(k) Number | K051883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2005 |
| Decision Date | August 05, 2005 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLT — Non-normalizing Quantitative Electroencephalograph Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User. |