K082315 is an FDA 510(k) clearance for the EC50 MICRO+ SMOKERLYZER. This device is classified as a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II - Special Controls, product code CCJ).
Submitted by Bedfont Scientific, Ltd. (Rochester, Kent, GB). The FDA issued a Cleared decision on February 1, 2010, 537 days after receiving the submission on August 13, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 868.1430.
| 510(k) Number | K082315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2008 |
| Decision Date | February 01, 2010 |
| Days to Decision | 537 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | CCJ - Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1430 |