The following data is part of a premarket notification filed by Rln Systems, Inc. with the FDA for Nerve Locator/monitor System, Modification.
| Device ID | K912508 |
| 510k Number | K912508 |
| Device Name: | NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION |
| Classification | Stimulator, Nerve |
| Applicant | RLN SYSTEMS, INC. 2019 HONEYSUCKLE LN. P.O. BOX 6757 Jefferson City, MO 65109 |
| Contact | Lee Rea |
| Correspondent | Lee Rea RLN SYSTEMS, INC. 2019 HONEYSUCKLE LN. P.O. BOX 6757 Jefferson City, MO 65109 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-06 |
| Decision Date | 1992-09-30 |