The following data is part of a premarket notification filed by Esaote Biomedica Spa with the FDA for Video Eeg Option Modification.
| Device ID | K933951 |
| 510k Number | K933951 |
| Device Name: | VIDEO EEG OPTION MODIFICATION |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | ESAOTE BIOMEDICA SPA 7990 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Wayne L Nethercutt |
| Correspondent | Wayne L Nethercutt ESAOTE BIOMEDICA SPA 7990 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-12 |
| Decision Date | 1994-02-03 |