The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Ihealth Align Mini Gluco-monitoring System.
| Device ID | K133790 |
| 510k Number | K133790 |
| Device Name: | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-05-22 |
| Summary: | summary |