The following data is part of a premarket notification filed by Eco-rx, Inc. with the FDA for Eco-rx Air Purifier With Uv Light, Model Rx-400.
| Device ID | K062716 |
| 510k Number | K062716 |
| Device Name: | ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | ECO-RX, INC. 34 AVENUE ST. DENIS Quebec City, Qc, CA G1r-4b6 |
| Contact | Constance R Brown, Esq. |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-12 |
| Decision Date | 2006-10-27 |