The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easyplus Mini R9n Self Monitoring Blood Glucose System Model Eps10031.
| Device ID | K101457 |
| 510k Number | K101457 |
| Device Name: | EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, Hsinchu, TW 300 |
| Contact | Y.c. Lei |
| Correspondent | Y.c. Lei EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City, Hsinchu, TW 300 |
| 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 | 2010-05-26 |
| Decision Date | 2010-07-01 |