The following data is part of a premarket notification filed by Compumedics Limited with the FDA for Orion Lifespan Meg.
| Device ID | K191785 |
| 510k Number | K191785 |
| Device Name: | Orion LifeSpan MEG |
| Classification | Magnetoencephalograph |
| Applicant | Compumedics Limited 30-40 Flockhart Street Abbotsford, AU 3067 |
| Contact | William Alam |
| Correspondent | William Alam Compumedics Limited 30-40 Flockhart Street Abbotsford, AU 3067 |
| Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2020-02-14 |