The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Fia Blood Glucose Monitoring System (g2).
| Device ID | K131173 |
| 510k Number | K131173 |
| Device Name: | FIA Blood Glucose Monitoring System (G2) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township, Hsinchu County, TW 305 |
| Contact | Axel Lin |
| Correspondent | Axel Lin HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township, Hsinchu County, TW 305 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-25 |
| Decision Date | 2014-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00389154000372 | K131173 | 000 |
| 00389154000495 | K131173 | 000 |