The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Infrarax Device.
| Device ID | K850852 |
| 510k Number | K850852 |
| Device Name: | INFRARAX DEVICE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
| Contact | James C Nicholas |
| Correspondent | James C Nicholas MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-08-21 |