The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Emv3 Self Monitoring Blood Glucose System, Emv3 Pro Self Monitoring Blood Glucose System.
| Device ID | K111728 |
| 510k Number | K111728 |
| Device Name: | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, Hsinchu, TW 30077 |
| Contact | Yc Lei |
| Correspondent | Yc Lei EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, Hsinchu, TW 30077 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2011-09-16 |