The following data is part of a premarket notification filed by Insta Nerve Canada, Inc. with the FDA for Insta-nerve(tm) Nerve Conduction Monitor.
| Device ID | K935298 |
| 510k Number | K935298 |
| Device Name: | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | INSTA NERVE CANADA, INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer INSTA NERVE CANADA, INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-02 |
| Decision Date | 1994-08-03 |