The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd. with the FDA for Med-link Pulse Oximeter.
| Device ID | K212752 |
| 510k Number | K212752 |
| Device Name: | Med-link Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Med-link Electronics Tech Co., Ltd. 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen, CN 518109 |
| Contact | Jialing Zhang |
| Correspondent | Jialing Zhang Shenzhen Med-link Electronics Tech Co., Ltd. 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen, CN 518109 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2022-05-20 |