The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Connect App For Ihealth Next, Ihealth React Native Sdk, Ihealth React Native Library Sdk, Ihealth Library Sdk, Ihealth Native Sdk.
| Device ID | K181541 |
| 510k Number | K181541 |
| Device Name: | Connect App For IHealth Next, IHealth React Native SDK, IHealth React Native Library SDK, IHealth Library SDK, IHealth Native SDK |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Andon Health Co., Ltd No.3 Jinping Street,Ya An Road, Nankai District Tianjin, P.R. China Tianjin, CN 300190 |
| Contact | Yi Liu |
| Correspondent | Yi Liu Andon Health Co., Ltd No.3 Jinping Street,Ya An Road, Nankai District Tianjin, P.R. China Tianjin, CN 300190 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2019-04-16 |