The following data is part of a premarket notification filed by Rosys, Inc. with the FDA for Plato 3300/1300.
| Device ID | K943454 |
| 510k Number | K943454 |
| Device Name: | PLATO 3300/1300 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ROSYS, INC. 1309 VEALE RD. SUITE 21 Wilmington, DE 19810 |
| Contact | Lee Carter |
| Correspondent | Lee Carter ROSYS, INC. 1309 VEALE RD. SUITE 21 Wilmington, DE 19810 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1995-01-09 |