The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Goodlife Ac-300 Blood Glucose Monitoring System, Goodlife Ac-301 Blood Glucose Monitoring System, Goodlife Ac-302 Blood Glucose Monitoring System, Goodlife Ac 303 Blood Glucose Monitoring System, Goodlife Ac-304 Blood Glucose Monitoring System Goodli.
| Device ID | K140150 |
| 510k Number | K140150 |
| Device Name: | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodli |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HMD BIOMEDICAL, INC. No 181 Minsheng St, Xinpu Township Hsinchu County, TW 305 |
| Contact | Axel Lin |
| Correspondent | Axel Lin HMD BIOMEDICAL, INC. No 181 Minsheng St, Xinpu Township Hsinchu County, TW 305 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2015-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00389154000501 | K140150 | 000 |
| 00389154000198 | K140150 | 000 |
| 00389454000525 | K140150 | 000 |
| 00868665000045 | K140150 | 000 |
| 04711200721850 | K140150 | 000 |
| 03894540005253 | K140150 | 000 |