The following data is part of a premarket notification filed by Brainz Instruments Ltd. with the FDA for Brm3 Brain Monitor.
| Device ID | K071449 |
| 510k Number | K071449 |
| Device Name: | BRM3 BRAIN MONITOR |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | BRAINZ INSTRUMENTS LTD. 25 CARBINE ROAD MT. WELLINGTON PO BOX 51-078, PARURANGA Auckland, NZ |
| Contact | Chris Mander |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | OMA |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-24 |
| Decision Date | 2007-09-14 |
| Summary: | summary |