The following data is part of a premarket notification filed by Guangzhou Berrcom Medical Device Co., Ltd. with the FDA for Non-contact Infrared Thermometer, Models Jxb-315, Jxb-319, Jxb-320, Jxb-311.
| Device ID | K213082 |
| 510k Number | K213082 |
| Device Name: | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Guangzhou Berrcom Medical Device Co., Ltd. No.38 Huanzhen Xi Road, Dagang Town, Nansha District Guangzhou, CN 51147 |
| Contact | Zhigang Du |
| Correspondent | Yoyo Chen Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-23 |
| Decision Date | 2022-01-28 |