K991012 is an FDA 510(k) clearance for the SIEMENS INFINITY EEG POD. This device is classified as a Non-normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLT).
Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on June 24, 1999, 90 days after receiving the submission on March 26, 1999.
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 | K991012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1999 |
| Decision Date | June 24, 1999 |
| Days to Decision | 90 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. |