The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Nerve Integrity Monitor-2 (nim-2 Xl).
| Device ID | K934426 |
| 510k Number | K934426 |
| Device Name: | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) |
| Classification | Stimulator, Nerve |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-10 |
| Decision Date | 1994-05-13 |