K082886 is an FDA 510(k) clearance for the ZOOM-100DC. This device is classified as a Non-normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLT).
Submitted by Brainscope Company, Inc. (Washington, US). The FDA issued a Cleared decision on August 10, 2009, 314 days after receiving the submission on September 30, 2008.
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 | K082886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2008 |
| Decision Date | August 10, 2009 |
| Days to Decision | 314 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. |