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.
| Device ID | K112738 |
| 510k Number | K112738 |
| Device Name: | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE |
| 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 Lin |
| Correspondent | Yi Lin ANDON MEDICAL CO., LTD. NO.26 HANGYU RD. TIANJIN AIRPORT ECONOMIC AREA Tianjin, CN 300381 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-20 |
| Decision Date | 2011-09-30 |
| Summary: | summary |