The following data is part of a premarket notification filed by Sejoy Electronics & Instruments Co., Ltd. with the FDA for Digital Thermometer, Models Mt-1027, Mt-4127, Mt-1032, Mt-4132, Mt-4333, Mt-4326, Mt-4726, Mt-4335, Mt-4735, Mt-09, Mt-30, Mt-31, Mt-36.
| Device ID | K153149 |
| 510k Number | K153149 |
| Device Name: | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 |
| 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 | 2016-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850253007208 | K153149 | 000 |
| 20810038630230 | K153149 | 000 |