The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd with the FDA for Med-link Temp-pulse Oximeter.
| Device ID | K202743 |
| 510k Number | K202743 |
| Device Name: | Med-Link Temp-pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Med-link Electronics Tech Co., Ltd 4th Snf 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 Snf 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 | 2020-09-18 |
| Decision Date | 2021-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944414042857 | K202743 | 000 |