The following data is part of a premarket notification filed by Rln Systems, Inc. with the FDA for Rln Nerve Locator/monitor; Model A.
Device ID | K925008 |
510k Number | K925008 |
Device Name: | RLN NERVE LOCATOR/MONITOR; MODEL A |
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 | 1992-10-02 |
Decision Date | 1992-11-24 |