The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Ihealth Wireless Smart Gluco-monitoring System (ihealth Gluco+).
| Device ID | K181070 |
| 510k Number | K181070 |
| Device Name: | IHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-23 |
| Decision Date | 2019-02-01 |
| Summary: | summary |