The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Fingertip Pulse Oximeter.
| Device ID | K161938 |
| 510k Number | K161938 |
| Device Name: | Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD 4F BUILDING C8, 40 JINGSHAN ROAD, ECONONIC AND TECHNOLGICAL DEVELOPMENT ZONE Xuzhou, CN 102628 |
| Contact | Yanli Li |
| Correspondent | Ray Wang BEIJING BELIEVE TECHNOLOGY SERVICE CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD. Li Yuan Town, Tongzhou District, Beijing, CN 101121 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2017-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06921745200026 | K161938 | 000 |