The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Zee Electrode-gel.
Device ID | K812284 |
510k Number | K812284 |
Device Name: | ZEE ELECTRODE-GEL |
Classification | Media, Electroconductive |
Applicant | ZEE MEDICAL PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-13 |
Decision Date | 1981-09-08 |