The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Infrared Ear Thermometer.
| Device ID | K111637 |
| 510k Number | K111637 |
| Device Name: | INFRARED EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 30075 |
| Contact | Lynn Chen |
| Correspondent | Lynn Chen RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 30075 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-12-06 |
| Summary: | summary |