The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Anesthesia & Brain Monitor.
| Device ID | K821910 |
| 510k Number | K821910 |
| Device Name: | ANESTHESIA & BRAIN MONITOR |
| Classification | Electromyograph, Diagnostic |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-28 |
| Decision Date | 1982-09-07 |