K112958 is an FDA 510(k) clearance for the HUMID-VENT HEPA. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on September 21, 2012, 352 days after receiving the submission on October 5, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K112958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2011 |
| Decision Date | September 21, 2012 |
| Days to Decision | 352 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 |