The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Rii Multi-function Infrared Thermometer, Model Th52z.
| Device ID | K162083 |
| 510k Number | K162083 |
| Device Name: | RII Multi-function Infrared Thermometer, Model TH52Z |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Radiant Innovation Inc. 1F, No.3 Industrial E. 9th Rd. Science-Based, Industrial Park Hsinchu, TW 30075 |
| Contact | Monica Chung |
| Correspondent | Monica Chung 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2017-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810025921088 | K162083 | 000 |