I-Sens, Inc. · Class II · Cleared Oct 17, 2008
| K-number | K080923 |
| Device name | CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB |
| Applicant | I-Sens, Inc. |
| Product code | NBW |
| Device class | Class II |
| Decision date | Oct 17, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
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