The following data is part of a premarket notification filed by Tianjin Empecs Medical Device Co., Ltd. with the FDA for Medisign Blood Glucose Monitoring System.
| Device ID | K111456 |
| 510k Number | K111456 |
| Device Name: | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. RM 1301, GYEONGGI VENT. ANYANG SCI UNIV., 572-5 ANYANG 8-DONG Manan-gu Anyang-si Gyeonggi-do, KR 430-731 |
| Contact | Hl Jung |
| Correspondent | Hl Jung TIANJIN EMPECS MEDICAL DEVICE CO., LTD. RM 1301, GYEONGGI VENT. ANYANG SCI UNIV., 572-5 ANYANG 8-DONG Manan-gu Anyang-si Gyeonggi-do, KR 430-731 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-25 |
| Decision Date | 2012-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10370393211053 | K111456 | 000 |
| 00383568100727 | K111456 | 000 |
| 10383568100731 | K111456 | 000 |
| 10383568100748 | K111456 | 000 |
| 00383568100758 | K111456 | 000 |
| 10673486000719 | K111456 | 000 |
| 20888277409184 | K111456 | 000 |
| 20888277409177 | K111456 | 000 |
| 10888277409163 | K111456 | 000 |
| 00854067005191 | K111456 | 000 |
| 10370393210209 | K111456 | 000 |
| 00383568100710 | K111456 | 000 |