The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Rii Infrared Ear Thermometer,.
| Device ID | K102187 |
| 510k Number | K102187 |
| Device Name: | RII INFRARED EAR THERMOMETER, |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
| Contact | James Huang |
| Correspondent | James Huang RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-03 |
| Decision Date | 2010-12-10 |
| Summary: | summary |