The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Digital Thermometer Mt Series.
| Device ID | K110776 |
| 510k Number | K110776 |
| Device Name: | DIGITAL THERMOMETER MT SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. WEST LAKE ECONOMY & TECHNOLOGY ZONE Hangzhou, Zhejiang, CN 310030 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. WEST LAKE ECONOMY & TECHNOLOGY ZONE Hangzhou, Zhejiang, CN 310030 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20370393421015 | K110776 | 000 |
| 00854878007124 | K110776 | 000 |
| 00854878007117 | K110776 | 000 |