K121133 is an FDA 510(k) clearance for the CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW).
Submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on July 10, 2012, 88 days after receiving the submission on April 13, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K121133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2012 |
| Decision Date | July 10, 2012 |
| Days to Decision | 88 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |