The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Ihealth Align Gluco-monitoring System.
| Device ID | K153286 |
| 510k Number | K153286 |
| Device Name: | IHealth Align Gluco-Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Andon Health Co., Ltd No. 3 Jimping Street, Ya'am Road, Nankai District Tianjin, CN 300190 |
| Contact | Yi Liu |
| Correspondent | Yi Liu Andon Health Co., Ltd No. 3 Jimping Street, Ya'am Road, Nankai District 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 | 2015-11-12 |
| Decision Date | 2016-08-19 |
| Summary: | summary |