The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Disposable Spo2 Sensor.
| Device ID | K191279 |
| 510k Number | K191279 |
| Device Name: | Disposable SpO2 Sensor |
| Classification | Oximeter |
| Applicant | Shenzhen Caremed Medical Technology Co., Ltd. East Side, 3/F, C Building, Kelunte Low-Carbon Industries Gaofeng Community Dalang Office, Longhua District, Shenzhe, CN 518109 |
| Contact | Alan Xie |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-12-06 |