The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Infrared Ear Thermometer.
| Device ID | K153146 |
| 510k Number | K153146 |
| Device Name: | Infrared Ear Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. BUILDING 2, NO. 202, ZHENZHONG ROAD, WEST LAKE ECONOMY & TECHNOLOGY ZONE Hangzhou, CN 310030 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. BUILDING 2, NO. 202, ZHENZHONG ROAD, WEST LAKE ECONOMY & TECHNOLOGY ZONE Hangzhou, CN 310030 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850253007215 | K153146 | 000 |