The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Mdt2 Ble Self-monitoring Blood Glucose System.
| Device ID | K190189 |
| 510k Number | K190189 |
| Device Name: | MDT2 BLE 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, TW 30077 |
| Contact | Cynthia Hung |
| Correspondent | Rf Jain EPS Bio Technology Corp. No. 8 R&D RD.III Hsinchu Science Park Hsinchu, 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 | 2019-02-01 |
| Decision Date | 2019-11-01 |