K143150 is an FDA 510(k) clearance for the CO2 monitoring line with and without in-line filter. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on February 5, 2015, 94 days after receiving the submission on November 3, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K143150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2014 |
| Decision Date | February 05, 2015 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCK - Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |