The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easymax N Self Monitoring Blood Glucose System, Model: Eps08008.
| Device ID | K083099 |
| 510k Number | K083099 |
| Device Name: | EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | EPS BIO TECHNOLOGY CORP. 2 F,NO. 49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 30071 |
| Contact | Y. C Lei |
| Correspondent | Y. C Lei EPS BIO TECHNOLOGY CORP. 2 F,NO. 49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 30071 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-20 |
| Decision Date | 2009-01-16 |