The following data is part of a premarket notification filed by Andon Medical Co., Ltd. with the FDA for Ihealth Bg5/bg5l Wireless Smart Glucose Monitoring System.
| Device ID | K123935 |
| 510k Number | K123935 |
| Device Name: | IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON MEDICAL CO., LTD. NO.26 HANGYU RD. TIANJIN AIRPORT ECONOMIC AREA Tianjin, CN 300381 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON MEDICAL CO., LTD. NO.26 HANGYU RD. TIANJIN AIRPORT ECONOMIC AREA Tianjin, CN 300381 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-04-12 |
| Summary: | summary |