The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Ihealth Cloud.
| Device ID | K131203 |
| 510k Number | K131203 |
| Device Name: | IHEALTH CLOUD |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO., LTD NO. 3 JINPING ROAD,YA' AN STREET Tianjin, CN 300193 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON HEALTH CO., LTD NO. 3 JINPING ROAD,YA' AN STREET Tianjin, CN 300193 |
| Product Code | DXN |
| Subsequent Product Code | MNW |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2013-07-19 |
| Summary: | summary |