The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Evoport 100.
| Device ID | K863985 |
| 510k Number | K863985 |
| Device Name: | EVOPORT 100 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1987-01-29 |