The following data is part of a premarket notification filed by Guangzhou Berrcom Medical Device Co., Ltd. with the FDA for Infrared Thermometer Model Md-h30.
| Device ID | K191570 |
| 510k Number | K191570 |
| Device Name: | Infrared Thermometer Model MD-H30 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Guangzhou Berrcom Medical Device Co., Ltd. No.38 Huanzhen Xi Road, Dagang Town, Nansha Guangzhou, CN 511470 |
| Contact | Zhigang Du |
| Correspondent | Christy Young Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road, 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 | 2019-06-13 |
| Decision Date | 2019-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10085239956943 | K191570 | 000 |
| 20810125111871 | K191570 | 000 |
| 56947656115902 | K191570 | 000 |
| 56947656116091 | K191570 | 000 |