The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Olympic Brainz Monitor Model Obm70001.
| Device ID | K093949 |
| 510k Number | K093949 |
| Device Name: | OLYMPIC BRAINZ MONITOR MODEL OBM70001 |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-06-16 |