The following data is part of a premarket notification filed by Taugagreining Hf with the FDA for Nervus Monitor.
| Device ID | K021185 |
| 510k Number | K021185 |
| Device Name: | NERVUS MONITOR |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | TAUGAGREINING HF PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith TAUGAGREINING HF PO BOX 4341 Crofton, MD 21114 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-15 |
| Decision Date | 2002-07-12 |