The following data is part of a premarket notification filed by Shenzhen Yimi Life-technology Co.,ltd. with the FDA for Pulse Oximeter.
| Device ID | K191430 |
| 510k Number | K191430 |
| Device Name: | Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Shenzhen Yimi Life-Technology Co.,Ltd. 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan Shenzhen, CN 518118 |
| Contact | Shande Peng |
| Correspondent | Shande Peng Shenzhen Yimi Life-Technology Co.,Ltd. 305 Tengbo Industrial Park, Changshangjiang Street, Longbei Village, Pingshan Shenzhen, CN 518118 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-29 |
| Decision Date | 2019-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972911370043 | K191430 | 000 |
| 06972911370036 | K191430 | 000 |
| 06972911370029 | K191430 | 000 |
| 06972911370012 | K191430 | 000 |
| 06972911370005 | K191430 | 000 |
| 00859811009258 | K191430 | 000 |
| 10628055787454 | K191430 | 000 |
| 00628055787440 | K191430 | 000 |
| 10859020006151 | K191430 | 000 |