K062533 is an FDA 510(k) clearance for the BWII EEG DIGITAL, MODEL PV 1652. This device is classified as a Non-normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLT).
Submitted by Neurovirtual USA, Inc. (Doral, US). The FDA issued a Cleared decision on December 22, 2006, 115 days after receiving the submission on August 29, 2006.
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 | K062533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2006 |
| Decision Date | December 22, 2006 |
| Days to Decision | 115 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. |