The following data is part of a premarket notification filed by Xinkang Medical Instrument Co. Ltd. with the FDA for Reusable And Disposable Spo2 Sensors.
| Device ID | K201360 |
| 510k Number | K201360 |
| Device Name: | Reusable And Disposable SpO2 Sensors |
| Classification | Oximeter |
| Applicant | Xinkang Medical Instrument Co. Ltd. 2 Floor, Puhua S&T Park, Tongsheng Community Dalang Street, Longhua District Shenzhen, CN 518109 |
| Contact | Xu Changsheng |
| Correspondent | James Tsai Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2020-08-19 |