The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Neuromuscular Transmission Monitor.
| Device ID | K840108 |
| 510k Number | K840108 |
| Device Name: | NEUROMUSCULAR TRANSMISSION MONITOR |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | DATEX DIVISION INSTRUMENTARIUM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-10 |
| Decision Date | 1984-02-17 |