The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Dual Chennel Brain Activity Monitor.
| Device ID | K843808 |
| 510k Number | K843808 |
| Device Name: | DUAL CHENNEL BRAIN ACTIVITY MONITOR |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 357 SF-00101 Helsinki 10 Finland , |
| Contact | Olli Riikkala |
| Correspondent | Olli Riikkala DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 357 SF-00101 Helsinki 10 Finland , |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1984-11-08 |