The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Fingertip Pulse Oximeter.
| Device ID | K121697 |
| 510k Number | K121697 |
| Device Name: | FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-10-15 |
| Summary: | summary |