K020745 is an FDA 510(k) clearance for the COSMED MICROQUARK. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Cosmed Srl (West Cadwell, US). The FDA issued a Cleared decision on January 2, 2003, 301 days after receiving the submission on March 7, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K020745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2002 |
| Decision Date | January 02, 2003 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTY - Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |