The following data is part of a premarket notification filed by Apex Bio Technology Corp. with the FDA for Bgm009 Plus Blood Glucose Monitoring System.
| Device ID | K170267 |
| 510k Number | K170267 |
| Device Name: | BGM009 Plus Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Apex Bio Technology Corp. No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, TW 30078 |
| Contact | Hsue-mei Lee |
| Correspondent | Hsue-mei Lee Apex Bio Technology Corp. No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, TW 30078 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-03-09 |
| Summary: | summary |