K112077 is an FDA 510(k) clearance for the HBIDB - HUMAN BRIAN INDEX SOFTWARE. This device is classified as a Normalizing Quantitative Electroencephalograph Software (Class II - Special Controls, product code OLU).
Submitted by Corscience GmbH & Co. KG (Monroeville, US). The FDA issued a Cleared decision on March 9, 2012, 232 days after receiving the submission on July 21, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User..
| 510(k) Number | K112077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2011 |
| Decision Date | March 09, 2012 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLU - Normalizing Quantitative Electroencephalograph Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User. |