The following data is part of a premarket notification filed by Idt Technology Limited with the FDA for Ft101 Forehead Thermometer; Ft101 Infrared Digital Thermometer.
| Device ID | K020433 |
| 510k Number | K020433 |
| Device Name: | FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | IDT TECHNOLOGY LIMITED P.O. BOX 391117 Solon, OH 44139 |
| Contact | James J Rogers |
| Correspondent | James J Rogers IDT TECHNOLOGY LIMITED P.O. BOX 391117 Solon, OH 44139 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-08 |
| Decision Date | 2002-07-11 |
| Summary: | summary |