The following data is part of a premarket notification filed by Shenzhen Brav Electronic Technologies Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K171214 |
| 510k Number | K171214 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Brav Electronic Technologies Co., Ltd. 4/F, Block 11, Tongfuyu Industrial District Huangmabu, Xixiang, Bao'an Shenzhen, CN 518102 |
| Contact | Aaron Wan |
| Correspondent | Ivy Chen Shenzhen Brav Electronic Technologies Co., Ltd. 4/F, Block 11, Tongfuyu Industrial District Huangmabu, Xixiang, Bao'an Shenzhen, CN 518102 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-25 |
| Decision Date | 2018-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00372217003014 | K171214 | 000 |
| 00861910000340 | K171214 | 000 |
| 00860001273717 | K171214 | 000 |
| 06926347901630 | K171214 | 000 |
| 06926347901623 | K171214 | 000 |
| 06926347901616 | K171214 | 000 |
| 06926347911615 | K171214 | 000 |
| 06926347917419 | K171214 | 000 |