The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easymax Mu Self Monitoring Blood Glucose System, Easymax Mu Pro Self Monitoring Blood Glucose System.
| Device ID | K121207 |
| 510k Number | K121207 |
| Device Name: | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| 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 | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-20 |
| Decision Date | 2012-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885017000065 | K121207 | 000 |
| 00885017000324 | K121207 | 000 |
| 01885017000101 | K121207 | 000 |