The following data is part of a premarket notification filed by Shenzhen Hexin Zondan Medical Equipment Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K203854 |
| 510k Number | K203854 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. Floor 14, Block D, Dianlian Technology Building, the Crossing Between South Circle Road And South Fuli Road, Shenzhen, CN 518106 |
| Contact | John Liu |
| Correspondent | John Liu Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. Floor 14, Block D, Dianlian Technology Building, the Crossing Between South Circle Road And South Fuli Road, Shenzhen, CN 518106 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-31 |
| Decision Date | 2021-04-23 |