The following data is part of a premarket notification filed by Life Science Technology Inc. with the FDA for Femon Banana Thermometer.
| Device ID | K180767 |
| 510k Number | K180767 |
| Device Name: | FEMON Banana Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Life Science Technology Inc. Suite B-1207, Gangseo Hangang Xi Tower, Yangcheon-ro 401, Gangseo-gu Seoul, KR 07528 |
| Contact | Jaewoo Jun |
| Correspondent | Priscilla Chung LK Consulting Group USA Inc. 690 Roosevelt Irvine, CA 92620 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2019-01-22 |
| Summary: | summary |