The following data is part of a premarket notification filed by Andon Medical Co., Ltd. with the FDA for Andon Health Care Management System Software, Ag-608 Single & Ag-608 Multi Blood Glucose Monitoring Systems.
| Device ID | K102678 |
| 510k Number | K102678 |
| Device Name: | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ANDON MEDICAL CO., LTD. NO. 04-23-3 AIRPORT INDUSTRIAL PARK, TIANJIN Tianjin, CN 300381 |
| Contact | Yi Liu |
| Correspondent | Yi Liu ANDON MEDICAL CO., LTD. NO. 04-23-3 AIRPORT INDUSTRIAL PARK, TIANJIN Tianjin, CN 300381 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-16 |
| Decision Date | 2011-08-26 |
| Summary: | summary |