The following data is part of a premarket notification filed by Algotek, Inc. with the FDA for Emg-1, Motor Nerve Monitor.
| Device ID | K864408 |
| 510k Number | K864408 |
| Device Name: | EMG-1, MOTOR NERVE MONITOR |
| Classification | Electromyograph, Diagnostic |
| Applicant | ALGOTEK, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Maurizio Liverani |
| Correspondent | Maurizio Liverani ALGOTEK, INC. 2464 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-10 |
| Decision Date | 1987-01-30 |