The following data is part of a premarket notification filed by Medical Intelcom, Inc. with the FDA for Blood Gas Expersystem 8700.
Device ID | K833430 |
510k Number | K833430 |
Device Name: | BLOOD GAS EXPERSYSTEM 8700 |
Classification | Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease |
Applicant | MEDICAL INTELCOM, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
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 | 1983-10-05 |
Decision Date | 1984-02-10 |