The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd. with the FDA for Med-link Temperature Probes.
| Device ID | K182667 |
| 510k Number | K182667 |
| Device Name: | Med-link Temperature Probes |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Med-link Electronics Tech Co., Ltd. 4th Fl, Bldg A, Yingtailong Industrial Park Dalang South Road, Longhua District Shenzhen, CN 518109 |
| Contact | Baihan Feng |
| Correspondent | Baihan Feng Shenzhen Med-link Electronics Tech Co., Ltd. 4th Fl, Bldg A, Yingtailong Industrial Park Dalang South Road, Longhua District Shenzhen, CN 518109 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2019-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944414050005 | K182667 | 000 |
| 06944414006910 | K182667 | 000 |