The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Ihealth Align Gluco-monitoring System, Ihealth Bg5 Wireless Smart Gluco-monitoring System, Ihealth Bg5l Wireless Smart Gluco-monitoring System.
| Device ID | K150833 |
| 510k Number | K150833 |
| Device Name: | IHealth Align Gluco-Monitoring System, IHealth BG5 Wireless Smart Gluco-Monitoring System, IHealth BG5L Wireless Smart Gluco-Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON HEALTH CO.,LTD NO 3, JINPING RD, YA AN ST NANKAI DISTRICT Tianjin, CN 300193 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON HEALTH CO.,LTD NO 3, JINPING RD, YA AN ST NANKAI DISTRICT Tianjin, CN 300193 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-12-04 |
| Summary: | summary |