The following data is part of a premarket notification filed by Shenzhen Calibeur Industries Co., Ltd. with the FDA for Infared Thermometer.
| Device ID | K191251 |
| 510k Number | K191251 |
| Device Name: | Infared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Calibeur Industries Co., Ltd. No. 11 Bldg., Shiguan Industrial Park, Gongming, Guangming New District Shenzhen, CN |
| Contact | Weibin He |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-09 |
| Decision Date | 2019-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970000910828 | K191251 | 000 |
| 00810477022852 | K191251 | 000 |
| 00810477022838 | K191251 | 000 |
| 00810477023668 | K191251 | 000 |
| 00810477023606 | K191251 | 000 |
| 00810477023613 | K191251 | 000 |
| 00810477022869 | K191251 | 000 |
| 00810477022883 | K191251 | 000 |
| 00810477021749 | K191251 | 000 |
| 06970000910132 | K191251 | 000 |
| 06970000910170 | K191251 | 000 |
| 06970000910811 | K191251 | 000 |
| 00810477022876 | K191251 | 000 |