The following data is part of a premarket notification filed by E-care Technology Co., Ltd. with the FDA for Swaive Thermometer Swt1a.
| Device ID | K170723 |
| 510k Number | K170723 |
| Device Name: | Swaive Thermometer SWT1A |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | E-Care Technology Co., Ltd. 8F-11, No. 35, Hsintai Road Chubei, TW 302 |
| Contact | K.y. Ko |
| Correspondent | K.y. Ko E-Care Technology Co., Ltd. 8F-11, No. 35, Hsintai Road Chubei, TW 302 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2018-10-25 |
| Summary: | summary |