The following data is part of a premarket notification filed by Xiamen Acurio Instruments Co., Ltd with the FDA for As-3xx Series Fingertip Pulse Oximeter.
| Device ID | K180685 |
| 510k Number | K180685 |
| Device Name: | AS-3XX Series Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen, CN 361026 |
| Contact | Angel Liu |
| Correspondent | Angel Liu Xiamen Acurio Instruments Co., Ltd 3rd-4th Floors, BI Park, No.2028 Wengjiao West Road, Haicang District Xiamen, CN 361026 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-15 |
| Decision Date | 2018-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16972382160188 | K180685 | 000 |
| 16972382160225 | K180685 | 000 |
| 16972382160249 | K180685 | 000 |
| 16972382160201 | K180685 | 000 |
| 10810053630010 | K180685 | 000 |
| 16972382160256 | K180685 | 000 |