I-Sens, Inc. · Class II · Cleared Jun 5, 2012
| K-number | K120759 |
| Device name | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION |
| Applicant | I-Sens, Inc. |
| Product code | CGA |
| Device class | Class II |
| Decision date | Jun 5, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov