The following data is part of a premarket notification filed by Evolutionary Systems, Inc. with the FDA for Stimulator, E.s.i. Neuro.
| Device ID | K781670 |
| 510k Number | K781670 |
| Device Name: | STIMULATOR, E.S.I. NEURO |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EVOLUTIONARY SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-03 |
| Decision Date | 1978-11-07 |