K014063 is an FDA 510(k) clearance for the TASK FORCE MONITOR 3040. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Cnsystems Medizintechnik GmbH (Europe, AT). The FDA issued a Cleared decision on February 7, 2002, 58 days after receiving the submission on December 11, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K014063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2001 |
| Decision Date | February 07, 2002 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSB - Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |