The following data is part of a premarket notification filed by Tianjin Empecs Medical Device Co., Ltd. with the FDA for Medisign Mm1000 Bt Blood Glucose Monitoring System, Medisign Mm1100 Bt Blood Glucose Monitoring System, Medisign Mm1200 Bt Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign Mm 1000 Bt Multi Blood Gluc.
| Device ID | K152534 |
| 510k Number | K152534 |
| Device Name: | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Gluc |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. NO.35 AND 37, YINGCHENG STREET Hangu, CN 300480 |
| Contact | Chae Chung Lyuel |
| Correspondent | Jigar Shah MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-04 |
| Decision Date | 2017-03-21 |
| Summary: | summary |