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 | K954601 |
| 510k Number | K954601 |
| Device Name: | NERVE LOCATOR/MONITOR SYSTEM MODIFICATION |
| Classification | Stimulator, Nerve |
| Applicant | RLN SYSTEMS, INC. 1021 NORTHEAST DR. Jefferson City, MO 65109 |
| Contact | J. Lee Rea |
| Correspondent | J. Lee Rea RLN SYSTEMS, INC. 1021 NORTHEAST DR. 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 | 1995-09-12 |
| Decision Date | 1995-12-22 |