The following data is part of a premarket notification filed by Brainz Instruments Ltd. with the FDA for Brm2 Brain Monitor.
| Device ID | K033010 |
| 510k Number | K033010 |
| Device Name: | BRM2 BRAIN MONITOR |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | BRAINZ INSTRUMENTS LTD. 25 CARBINE ROAD MT. WELLINGTON PO BOX 51-078, PARURANGA Auckland, NZ |
| Contact | Chris Mander |
| Correspondent | Denise L Klinker UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | OLT |
| Subsequent Product Code | GXY |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2003-10-10 |
| Summary: | summary |