The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Infrared Thermometer Model E127.
| Device ID | K201161 |
| 510k Number | K201161 |
| Device Name: | Infrared Thermometer Model E127 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, CN 518116 |
| Contact | Yiqing Feng |
| Correspondent | Yiqing Feng Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, CN 518116 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-30 |
| Decision Date | 2020-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939184620008 | K201161 | 000 |