The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Em40 Self-monitoring Blood Glucose System.
| Device ID | K133389 |
| 510k Number | K133389 |
| Device Name: | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City,, TW 30077 |
| Contact | Cynthia Hung |
| Correspondent | Cynthia Hung EPS BIO TECHNOLOGY CORP. NO.8 R&D RD III HSINCHU SCIENCE PARK Hsinchu City,, TW 30077 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-05 |
| Decision Date | 2014-04-15 |
| Summary: | summary |