The following data is part of a premarket notification filed by Shenzhen Coreray Technology, Ltd. with the FDA for Reusable & Disposable Spo2 Sensors.
| Device ID | K173368 |
| 510k Number | K173368 |
| Device Name: | Reusable & Disposable SpO2 Sensors |
| Classification | Oximeter |
| Applicant | Shenzhen Coreray Technology, Ltd. ChuangYe Technology Park 1th Dong Huan Road, Longhua New District Shenzhen, CN 518109 |
| Contact | Simon Fan |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. 1122#, International MMayor Communication Center Shizhou Zhong Road 55#, Na Shenzhen, CN 518100 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-26 |
| Decision Date | 2018-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928737883526 | K173368 | 000 |