The following data is part of a premarket notification filed by Brc Operations Pty Limited with the FDA for Brc Software Product.
| Device ID | K050192 |
| 510k Number | K050192 |
| Device Name: | BRC SOFTWARE PRODUCT |
| Classification | Normalizing Quantitative Electroencephalograph Software |
| Applicant | BRC OPERATIONS PTY LIMITED 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham BRC OPERATIONS PTY LIMITED 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | OLU |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-27 |
| Decision Date | 2005-10-20 |
| Summary: | summary |