K092218 is an FDA 510(k) clearance for the FLEXICARE BREATHING FILTERS. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Flexicare Medical, Ltd. (Mid Glam, GB). The FDA issued a Cleared decision on October 6, 2009, 76 days after receiving the submission on July 22, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K092218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2009 |
| Decision Date | October 06, 2009 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |