The following data is part of a premarket notification filed by Easywell Biomedicals, Inc. with the FDA for Infrared Non-contact Thermometer, Model Act8100.
| Device ID | K162509 |
| 510k Number | K162509 |
| Device Name: | Infrared Non-contact Thermometer, Model ACT8100 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | EASYWELL BIOMEDICALS, INC. SUITE 2, 2F, NO.9, JHANYE 1ST RD, HSINCHU SCIENCE PARK , Hsinchu, TW 30078 |
| Contact | Arthur Chen |
| Correspondent | Arthur Chen EASYWELL BIOMEDICALS, INC. SUITE 2, 2F, NO.9, JHANYE 1ST RD, HSINCHU SCIENCE PARK , Hsinchu, TW 30078 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-08 |
| Decision Date | 2017-03-10 |
| Summary: | summary |