The following data is part of a premarket notification filed by Apk Technology Co., Ltd. with the FDA for Reusable Spo2 Sensors, Disposable Spo2 Sensors.
| Device ID | K172981 |
| 510k Number | K172981 |
| Device Name: | Reusable SpO2 Sensors, Disposable SpO2 Sensors |
| Classification | Oximeter |
| Applicant | APK Technology Co., Ltd. 6Floor, B2 Building, Industry Of Hengfeng Hezhou, Xixiang, Bao'an Distric Shenzhen, CN 518126 |
| Contact | Caifang Wang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-06-08 |
| Summary: | summary |