The following data is part of a premarket notification filed by Tianjin Empecs Medical Device Co.,ltd. with the FDA for Medisign Gh81 Blood Glucose Monitoring System, Medisign Gh82 Blood Glucose Monitoring System, Medisign Gh83 Blood Glucose Monitoring System, Medisign Gh81 Bt Blood Glucose Monitoring System, Medisign Gh82 Bt Blood Glucose Monitoring System, Medisign .
| Device ID | K162564 |
| 510k Number | K162564 |
| Device Name: | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Tianjin Empecs Medical Device Co.,Ltd. No. 35 And 37, Yingcheng Street, Hangu Binhai New Area Yingcheng Street Tianjin, CN 300480 |
| Contact | Chae Chung Lyuel |
| Correspondent | Priscilla Chung Tianjin Empecs Medical Device Co.,Ltd. 690 Roosevelt Irvine, CA 92620 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2017-06-07 |
| Summary: | summary |