The following data is part of a premarket notification filed by Sedatelec with the FDA for Premio 10 Moxa.
| Device ID | K101267 |
| 510k Number | K101267 |
| Device Name: | PREMIO 10 MOXA |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | SEDATELEC 5401 S. COTTONWOOD COURT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SEDATELEC 5401 S. COTTONWOOD COURT Greenwood Village, CO 80121 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-05 |
| Decision Date | 2010-12-03 |
| Summary: | summary |