The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Non-contact Clinical Thermometer.
| Device ID | K121428 |
| 510k Number | K121428 |
| Device Name: | NON-CONTACT CLINICAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIANT INNOVATION INC. 1F, NO.3, INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 30075 |
| Contact | James Huang |
| Correspondent | James Huang 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 | 2012-05-14 |
| Decision Date | 2012-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884392626024 | K121428 | 000 |
| 50666519700036 | K121428 | 000 |
| 10860003705305 | K121428 | 000 |
| 00194484319427 | K121428 | 000 |
| 00860003705315 | K121428 | 000 |
| 00840177900006 | K121428 | 000 |
| 00073796507206 | K121428 | 000 |