The following data is part of a premarket notification filed by Broadmaster Biotech, Corp. with the FDA for Advocate Non-contact Infrared Thermometer.
| Device ID | K180355 |
| 510k Number | K180355 |
| Device Name: | Advocate Non-Contact Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist. Taoyuan, TW 32057 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen Chinese-European Industrial Research Society No. 58, Fu-Chiun St Hsin-chu City, TW 30067 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2019-01-10 |
| Summary: | summary |