The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Rii Infrared Ear Thermometer, Models Th00xy Series.
| Device ID | K051269 |
| 510k Number | K051269 |
| Device Name: | RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES |
| 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 | 2005-05-17 |
| Decision Date | 2005-09-09 |
| Summary: | summary |