The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Inivox Electrode/catheter Sys.
Device ID | K832916 |
510k Number | K832916 |
Device Name: | INIVOX ELECTRODE/CATHETER SYS |
Classification | Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease |
Applicant | CRITIKON COMPANY,LLC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LLE |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-29 |
Decision Date | 1983-11-14 |