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 |