The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Radiant Innovation Inc. Infrared Ear Thermometer, Models Th1 Series.
| Device ID | K030324 |
| 510k Number | K030324 |
| Device Name: | RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIANT INNOVATION, INC. NO. 40 LANE 19, BADE RD. Hsinchu City, TW 300 |
| Contact | Charles Chang |
| Correspondent | Charles Chang RADIANT INNOVATION, INC. NO. 40 LANE 19, BADE RD. Hsinchu City, 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 | 2003-01-31 |
| Decision Date | 2003-02-27 |
| Summary: | summary |