The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Ihealth Align Gluco-monitoring System (bg1); Ihealth Wireless Smart Gluco-monitoring System (bg5) .
| Device ID | K170231 |
| 510k Number | K170231 |
| Device Name: | IHealth Align Gluco-Monitoring System (BG1); IHealth Wireless Smart Gluco-Monitoring System (BG5) |
| 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 | 2017-01-25 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20856362005191 | K170231 | 000 |
| 10850044118264 | K170231 | 000 |
| 10850044118257 | K170231 | 000 |
| 10850044118202 | K170231 | 000 |