The following data is part of a premarket notification filed by Visidyne Corp. with the FDA for Pantops M-2 Electrophysiology System.
| Device ID | K810699 |
| 510k Number | K810699 |
| Device Name: | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM |
| Classification | Photostimulator, Ac-powered |
| Applicant | VISIDYNE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-16 |
| Decision Date | 1981-06-09 |