The following data is part of a premarket notification filed by Jiangsu Konsung Bio-medical Science & Technology Co. Ltd with the FDA for Fingertip Pulse Oximeter.
| Device ID | K152091 |
| 510k Number | K152091 |
| Device Name: | Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd NO. 8, Shengchang West Road,Danyang Economy Development Zone Jiang Su, CN |
| Contact | Li Xu |
| Correspondent | Li Xu Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd NO. 8, Shengchang West Road,Danyang Economy Development Zone Jiang Su, CN |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934822531234 | K152091 | 000 |
| 06934822531173 | K152091 | 000 |