The following data is part of a premarket notification filed by Micromedical Technologies, Inc. with the FDA for Visualeyes: Video Eye Monitor.
| Device ID | K964325 |
| 510k Number | K964325 |
| Device Name: | VISUALEYES: VIDEO EYE MONITOR |
| Classification | Nystagmograph |
| Applicant | MICROMEDICAL TECHNOLOGIES, INC. 110 WEST WALNUT Chatham, IL 62629 |
| Contact | Manish Sumant |
| Correspondent | Manish Sumant MICROMEDICAL TECHNOLOGIES, INC. 110 WEST WALNUT Chatham, IL 62629 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-30 |
| Decision Date | 1997-07-15 |