The following data is part of a premarket notification filed by Shenzhen Sino-k Medical Technology Co., Ltd. with the FDA for Disposable Spo2 Sensor.
| Device ID | K192608 |
| 510k Number | K192608 |
| Device Name: | Disposable SpO2 Sensor |
| Classification | Oximeter |
| Applicant | Shenzhen SINO-K Medical Technology Co., Ltd. Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, CN 518000 |
| Contact | Lao Chengxin |
| 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 | 2019-09-20 |
| Decision Date | 2020-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972820963787 | K192608 | 000 |
| 06972820960663 | K192608 | 000 |
| 06972820960670 | K192608 | 000 |
| 06972820960687 | K192608 | 000 |
| 06972820960700 | K192608 | 000 |
| 06972820960717 | K192608 | 000 |
| 06972820960724 | K192608 | 000 |
| 06972820960731 | K192608 | 000 |
| 06972820960748 | K192608 | 000 |
| 06972820960755 | K192608 | 000 |
| 06972820960656 | K192608 | 000 |