The following data is part of a premarket notification filed by Escalon Medical Corp. with the FDA for Megavision Cpx, Megavision Fa, Model I And Ii.
| Device ID | K002920 |
| 510k Number | K002920 |
| Device Name: | MEGAVISION CPX, MEGAVISION FA, MODEL I AND II |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | ESCALON MEDICAL CORP. 2440 SOUTH 179TH ST. New Berlin, WI 53146 |
| Contact | Ronald Hueneke |
| Correspondent | Richard Depiano ESCALON MEDICAL CORP. 2440 SOUTH 179TH ST. New Berlin, WI 53146 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-19 |
| Decision Date | 2000-12-18 |