The following data is part of a premarket notification filed by Tianjin Empecs Medical Device Co., Ltd. with the FDA for Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System.
| Device ID | K133260 |
| 510k Number | K133260 |
| Device Name: | MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung TIANJIN EMPECS MEDICAL DEVICE CO., LTD. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-23 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854067005238 | K133260 | 000 |