The following data is part of a premarket notification filed by Hubdic Co., Ltd with the FDA for The Infrared Forehead Thermometer, Model Fs-300&301.
| Device ID | K101912 |
| 510k Number | K101912 |
| Device Name: | THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HUBDIC CO., LTD 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung HUBDIC CO., LTD 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-09 |
| Decision Date | 2010-11-10 |
| Summary: | summary |