The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd. with the FDA for Shenzhen Med-link Pulse Oximeter Probe.
| Device ID | K113727 |
| 510k Number | K113727 |
| Device Name: | SHENZHEN MED-LINK PULSE OXIMETER PROBE |
| Classification | Oximeter |
| Applicant | SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. 144 RESEARCH DRIVE Hampton, VA 23666 |
| Contact | Rhonda Alexander |
| Correspondent | Rhonda Alexander SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. 144 RESEARCH DRIVE Hampton, VA 23666 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2013-03-21 |
| Summary: | summary |