The following data is part of a premarket notification filed by Brainz Instruments Ltd. with the FDA for Brm2 Brain Monitor.
| Device ID | K030489 |
| 510k Number | K030489 |
| 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 | Charles Mack UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-14 |
| Decision Date | 2003-05-02 |
| Summary: | summary |