The following data is part of a premarket notification filed by Radionics Medical, Inc. with the FDA for Corneomap 4500.
| Device ID | K844299 |
| 510k Number | K844299 |
| Device Name: | CORNEOMAP 4500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | RADIONICS MEDICAL, INC. 1240 ELLESMERE ROAD Scarborough, Ontario, Can, CA |
| Contact | William L Younder |
| Correspondent | William L Younder RADIONICS MEDICAL, INC. 1240 ELLESMERE ROAD Scarborough, Ontario, Can, CA |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-07 |
| Decision Date | 1985-04-18 |