The following data is part of a premarket notification filed by Fora Care Inc. with the FDA for Fora V10 Blood Glucose Monitoring System.
| Device ID | K121706 |
| 510k Number | K121706 |
| Device Name: | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | FORA CARE INC. 6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Pinjung Chen |
| Correspondent | Pinjung Chen FORA CARE INC. 6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-08 |
| Decision Date | 2013-01-14 |
| Summary: | summary |