The following data is part of a premarket notification filed by Neurotron Medical with the FDA for Nervepace(r) Nerve Conduction Viewscope (200vs).
| Device ID | K963208 |
| 510k Number | K963208 |
| Device Name: | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROTRON MEDICAL 2687 MAIN ST. Lawrenceville, NJ 08628 |
| Contact | Jack Guldalian, Jr. |
| Correspondent | Jack Guldalian, Jr. NEUROTRON MEDICAL 2687 MAIN ST. Lawrenceville, NJ 08628 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1997-07-14 |