The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Rii Infrared Ear Thermometer, Model Th01bn.
| Device ID | K070976 |
| 510k Number | K070976 |
| Device Name: | RII INFRARED EAR THERMOMETER, MODEL TH01BN |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, Hsin Chu, TW |
| Contact | Frank Lin |
| Correspondent | Frank Lin RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, Hsin Chu, TW |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-04-20 |
| Summary: | summary |