The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Sejoy Digital Thermometer, Mt Series (mt-201, Mt-301, Mt-402, Mt-403 And Mt-405).
| Device ID | K062784 |
| 510k Number | K062784 |
| Device Name: | SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 34 MCNAMARA STREET Stoughton, MA 02072 |
| Contact | Paul Ware |
| Correspondent | Paul Ware SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 34 MCNAMARA STREET Stoughton, MA 02072 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2007-05-04 |
| Summary: | summary |