K191322 is an FDA 510(k) clearance for the E-EEGX, N-EEGX. This device is classified as a Non-normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLT).
Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on January 22, 2020, 252 days after receiving the submission on May 15, 2019.
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 | K191322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2019 |
| Decision Date | January 22, 2020 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| 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. |