The following data is part of a premarket notification filed by Health & Life Co., Ltd with the FDA for Non-contact Infrared Thermometer, Model Hl710h.
| Device ID | K211744 |
| 510k Number | K211744 |
| Device Name: | Non-Contact Infrared Thermometer, Model HL710H |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Health & Life Co., Ltd 9F, No. 186, Jian Yi Road Zhonghe District New Taipei, TW 23553 |
| Contact | Simon Lee |
| Correspondent | Melody Jiang Health & Life Co., Ltd 9F, No. 186, Jian Yi Road Zhonghe District New Taipei, TW 23553 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2021-11-24 |