The following data is part of a premarket notification filed by Corscience Gmbh & Co. Kg with the FDA for Hbidb - Human Brian Index Software.
| Device ID | K112077 |
| 510k Number | K112077 |
| Device Name: | HBIDB - HUMAN BRIAN INDEX SOFTWARE |
| Classification | Normalizing Quantitative Electroencephalograph Software |
| Applicant | CORSCIENCE GMBH & CO. KG 700-706 SECO RD Monroeville, PA 15146 |
| Contact | Patrik R Karem |
| Correspondent | Patrik R Karem CORSCIENCE GMBH & CO. KG 700-706 SECO RD Monroeville, PA 15146 |
| Product Code | OLU |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-21 |
| Decision Date | 2012-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251341900054 | K112077 | 000 |