The following data is part of a premarket notification filed by Honsun (nantong) Co., Ltd with the FDA for Infrared Forehead Thermometer Ld-ft-100b.
| Device ID | K211629 |
| 510k Number | K211629 |
| Device Name: | Infrared Forehead Thermometer LD-FT-100B |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Honsun (Nantong) Co., Ltd No.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, CN 226009 |
| Contact | Iris Du |
| Correspondent | Iris Du Honsun (Nantong) Co., Ltd No.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, CN 226009 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-27 |
| Decision Date | 2021-12-08 |