The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Pulsatron Nerve Locator/stimulator.
Device ID | K833646 |
510k Number | K833646 |
Device Name: | PULSATRON NERVE LOCATOR/STIMULATOR |
Classification | Stimulator, Nerve |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-17 |
Decision Date | 1984-02-10 |