The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Sein Blood Glucose And Blood Pressure Monitor System, Model Bgp-100.
| Device ID | K052108 |
| 510k Number | K052108 |
| Device Name: | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SEIN ELECTRONICS CO., LTD. 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour SEIN ELECTRONICS CO., LTD. 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-12-07 |
| Summary: | summary |