K091814 is an FDA 510(k) clearance for the FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 20, 2009, 155 days after receiving the submission on June 18, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K091814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2009 |
| Decision Date | November 20, 2009 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |