The following data is part of a premarket notification filed by Shenzhen Coreray Technology., Ltd with the FDA for Patient Monitoring Cable (spo2 Extension Cable).
| Device ID | K192404 |
| 510k Number | K192404 |
| Device Name: | Patient Monitoring Cable (SpO2 Extension Cable) |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Shenzhen Coreray Technology., Ltd 305, 307 Liangji Building, 1st Donghuan Road Longhua New District Shenzhen, CN 518109 |
| Contact | Simon Fan |
| Correspondent | Simon Fan Shenzhen Coreray Technology., Ltd 305, 307 Liangji Building, 1st Donghuan Road Longhua New District Shenzhen, CN 518109 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-06-22 |