The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Goodlife Cs-200 (single Patient Use), Cs-200 Professional (multiple Patient Use) Blood Glucose Monitoring Systems.
| Device ID | K121433 |
| 510k Number | K121433 |
| Device Name: | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township, Hsinchu County, TW 305 |
| Contact | Jessica Tung |
| Correspondent | Jessica Tung HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township, Hsinchu County, TW 305 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260236851166 | K121433 | 000 |
| 04711200722918 | K121433 | 000 |
| 04260236851326 | K121433 | 000 |
| 04260236851289 | K121433 | 000 |
| 04260236851319 | K121433 | 000 |
| 04260236851296 | K121433 | 000 |
| 04260236851265 | K121433 | 000 |
| 04260236851258 | K121433 | 000 |
| 04260236851272 | K121433 | 000 |
| 04260236851173 | K121433 | 000 |
| 04711200722901 | K121433 | 000 |