The following data is part of a premarket notification filed by Truly Instrument Limited with the FDA for Truly Infrared Ear Thermometer, Model Tet-350, Tet-360, Tet-370.
| Device ID | K090564 |
| 510k Number | K090564 |
| Device Name: | TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TRULY INSTRUMENT LIMITED TRULY INDUSTRIAL AREA Shanwei City, Guangdong, CN 516600 |
| Contact | Yang Jian-hao |
| Correspondent | Yang Jian-hao TRULY INSTRUMENT LIMITED TRULY INDUSTRIAL AREA Shanwei City, Guangdong, CN 516600 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-06-24 |
| Summary: | summary |