The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Sejoy, Model Mt-403.
| Device ID | K051699 |
| 510k Number | K051699 |
| Device Name: | SEJOY, MODEL MT-403 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 1255 SAN TOMAS AQUINO RD. #214 San Jose, CA 95117 |
| Contact | Jianyao Wu |
| Correspondent | Jianyao Wu SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 1255 SAN TOMAS AQUINO RD. #214 San Jose, CA 95117 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-24 |
| Decision Date | 2006-02-06 |