| Primary Device ID | 06430056480282 |
| NIH Device Record Key | e8414f23-20a0-4f6e-881d-a040ba5fbca0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEF electrode assembly |
| Version Model Number | NM21794K |
| Company DUNS | 538025107 |
| Company Name | Elekta Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06430056480282 [Primary] |
| OLY | Magnetoencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 06430056480008 - Elekta Neuromag® TRIUX | 2018-07-06 The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalo |
| 06430056480015 - Elekta Neuromag® TRIUX | 2018-07-06 The Elekta Neuromag® TRIUX non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalo |
| 06430056480022 - Data analysis software 3.4 | 2018-07-06 A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®. |
| 06430056480046 - Elekta Neuromag ® Data Analysis Software MaxFilter | 2018-07-06 |
| 06430056480053 - Patient chair | 2018-07-06 Adjustable patient chair with accessories for comfortable seated measurement position. |
| 06430056480060 - Patient couch | 2018-07-06 Patient couch for the supine measurement position. |
| 06430056480077 - Child insert for chair | 2018-07-06 A booster seat and neck collar for pediatric patients. |
| 06430056480084 - Auditory stimulator (earphones) | 2018-07-06 A binaural auditory stimulator for eliciting auditory evoked fields. |