The following data is part of a premarket notification filed by Neurotron, Inc. with the FDA for Digital Electroneurometer S-100.
Device ID | K843924 |
510k Number | K843924 |
Device Name: | DIGITAL ELECTRONEUROMETER S-100 |
Classification | Device, Nerve Conduction Velocity Measurement |
Applicant | NEUROTRON, INC. P.O. BOX 6480 Lawrenceville, NJ 08648 |
Contact | Jack Guldalian |
Correspondent | Jack Guldalian NEUROTRON, INC. P.O. BOX 6480 Lawrenceville, NJ 08648 |
Product Code | JXE |
CFR Regulation Number | 882.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-05 |
Decision Date | 1985-03-12 |