The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Apps-health01.
| Device ID | K122098 |
| 510k Number | K122098 |
| Device Name: | APPS-HEALTH01 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2013-03-21 |
| Summary: | summary |