K091185 is an FDA 510(k) clearance for the 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on July 24, 2009, 92 days after receiving the submission on April 23, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K091185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2009 |
| Decision Date | July 24, 2009 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |