The following data is part of a premarket notification filed by Hubdic Co., Ltd with the FDA for Digital Forehead Thermometer, Model Fs-100.
| Device ID | K043331 |
| 510k Number | K043331 |
| Device Name: | DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HUBDIC CO., LTD 11820 RED HIBISCUS DR. Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg HUBDIC CO., LTD 11820 RED HIBISCUS DR. Bonita Springs, FL 34135 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-03-04 |
| Summary: | summary |