The following data is part of a premarket notification filed by Eiminda Ltd. with the FDA for Bna Analysis System.
| Device ID | K121119 |
| 510k Number | K121119 |
| Device Name: | BNA ANALYSIS SYSTEM |
| Classification | Normalizing Quantitative Electroencephalograph Software |
| Applicant | EIMINDA LTD. 16 HAMINHARA ST. BEIT BACHAR Herzliya, IL 46586 |
| Contact | Dalia Dickman |
| Correspondent | Dalia Dickman EIMINDA LTD. 16 HAMINHARA ST. BEIT BACHAR Herzliya, IL 46586 |
| Product Code | OLU |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2014-07-25 |
| Summary: | summary |