K050927 is an FDA 510(k) clearance for the RT019 INSPIRATORY/EXPIRATORY FILTER. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Fisher &Paykel Healthcare , Ltd. (East Tamaki, Auckland, NZ). The FDA issued a Cleared decision on August 1, 2005, 110 days after receiving the submission on April 13, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K050927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2005 |
| Decision Date | August 01, 2005 |
| Days to Decision | 110 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 |